i Table of contents 397

Life Sciences 2025

Definitive global law guides offering comparative analysis from top-ranked lawyers

Contents		4
INTRODUCTION		6
Contributed by Lincoln Tsang, Ropes & Gray LLP		6
AUSTRIA		11
Law and Practice		11
Contributed by Herbst Kinsky Rechtsanwälte GmbH		11
Trends and Developments		33
Contributed by Herbst Kinsky Rechtsanwälte GmbH		33
BRAZIL		38
Law and Practice		38
Contributed by Kasznar Leonardos Intellectual Property		38
Trends and Developments		59
Contributed by Felsberg Advogados		59
CHINA		64
Law and Practice		64
Contributed by Global Law Office		64
Trends and Developments		84
Contributed by Han Kun Law Offices		84
FRANCE		94
Law and Practice		94
Contributed by McDermott Will & Emery		94
GERMANY		114
Trends and Developments		114
Contributed by D+B Lawyers		114
GREECE		119
Law and Practice		119
Contributed by ALG Manousakis Law Firm		119
Trends and Developments		143
Contributed by ALG Manousakis Law Firm		143
INDONESIA		148
Law and Practice		148
Contributed by Santoso, Martinus & Muliawan Advocates		148
ISRAEL		166
Law and Practice		166
Contributed by Reinhold Cohn Group		166
JAPAN		185
Law and Practice		185
Contributed by Nagashima Ohno & Tsunematsu		185
MEXICO		199
Law and Practice		199
Contributed by Baker McKenzie		199
Trends and Developments		219
Contributed by Galicia Abogados, SC		219
POLAND		227
Trends and Developments		227
Contributed by Kieltyka Gladkowski KG Legal		227
PORTUGAL		236
Law and Practice		236
Contributed by PLMJ		236
Trends and Developments		248
Contributed by Eversheds Sutherland		248
SERBIA		256
Law and Practice		256
Contributed by BDK Advokati		256
Trends and Developments		274
Contributed by BDK Advokati		274
SOUTH KOREA		280
Law and Practice		280
Contributed by Lee & Ko		280
Trends and Developments		296
Contributed by Lee & Ko		296
SPAIN		303
Law and Practice		303
Contributed by Faus Moliner		303
Trends and Developments		324
Contributed by Faus Moliner		324
SWITZERLAND		330
Law and Practice		330
Contributed by Bär & Karrer AG		330
Trends and Developments		349
Contributed by Wenger Plattner		349
UK		357
Law and Practice		357
Contributed by Arnold & Porter		357
USA		375
Law and Practice		375
Contributed by Arnold & Porter		375
Trends and Developments		390
Contributed by Ropes & Gray LLP		390
1. Life Sciences Regulatory Framework		14
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		14
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		15
1.3 Different Categories of Pharmaceuticals and Medical Devices		15
2. Clinical Trials		16
2.1 Regulation of Clinical Trials		16
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		16
2.3 Public Availability of the Conduct of a Clinical Trial		18
2.4 Restriction on Using Online Tools to Support Clinical Trials		18
2.5 Use of Data Resulting From Clinical Trials		18
2.6 Databases Containing Personal or Sensitive Data		19
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		19
3.1 Product Classification: Pharmaceuticals or Medical Devices		19
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		20
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		20
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		21
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		22
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		23
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		24
4. Regulatory Reliance and Fast Track Registration Routes		25
4.1 Fast Track Registration Routes		25
4.2 Regulatory Reliance		25
5. Manufacturing of Pharmaceuticals and Medical Devices		25
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		25
6. Distribution of Pharmaceuticals and Medical Devices		26
6.1 Wholesale of Pharmaceuticals and Medical Devices		26
6.2 Different Classifications Applicable to Pharmaceuticals		27
7. Import and Export of Pharmaceuticals and Medical Devices		27
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		27
7.2 Importer of Record of Pharmaceuticals and Medical Devices		27
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		28
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		28
7.5 Trade Blocs and Free Trade Agreements		29
8. Pharmaceutical and Medical Device Pricing and Reimbursement		29
8.1 Price Control for Pharmaceuticals and Medical Devices		29
8.2 Price Levels of Pharmaceuticals or Medical Devices		30
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		30
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		31
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		31
1. Life Sciences Regulatory Framework		42
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		42
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		42
1.3 Different Categories of Pharmaceuticals and Medical Devices		43
2. Clinical Trials		43
2.1 Regulation of Clinical Trials		43
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		44
2.3 Public Availability of the Conduct of a Clinical Trial		44
2.4 Restriction on Using Online Tools to Support Clinical Trials		45
2.5 Use of Data Resulting From Clinical Trials		45
2.6 Databases Containing Personal or Sensitive Data		45
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		45
3.1 Product Classification: Pharmaceuticals or Medical Devices		45
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		46
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		47
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		47
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		48
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		49
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		49
4. Regulatory Reliance and Fast Track Registration Routes		50
4.1 Fast Track Registration Routes		50
4.2 Regulatory Reliance		50
5. Manufacturing of Pharmaceuticals and Medical Devices		51
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		51
6. Distribution of Pharmaceuticals and Medical Devices		52
6.1 Wholesale of Pharmaceuticals and Medical Devices		52
6.2 Different Classifications Applicable to Pharmaceuticals		52
7. Import and Export of Pharmaceuticals and Medical Devices		52
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		52
7.2 Importer of Record of Pharmaceuticals and Medical Devices		53
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		53
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		54
7.5 Trade Blocs and Free Trade Agreements		54
8. Pharmaceutical and Medical Device Pricing and Reimbursement		55
8.1 Price Control for Pharmaceuticals and Medical Devices		55
8.2 Price Levels of Pharmaceuticals or Medical Devices		56
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		56
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		57
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		57
1. Life Sciences Regulatory Framework		68
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		68
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		69
1.3 Different Categories of Pharmaceuticals and Medical Devices		69
2. Clinical Trials		69
2.1 Regulation of Clinical Trials		69
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		70
2.3 Public Availability of the Conduct of a Clinical Trial		71
2.4 Restriction on Using Online Tools to Support Clinical Trials		71
2.5 Use of Data Resulting From Clinical Trials		71
2.6 Databases Containing Personal or Sensitive Data		72
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		72
3.1 Product Classification: Pharmaceuticals or Medical Devices		72
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		73
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		73
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		73
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		74
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		75
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		76
4. Regulatory Reliance and Fast Track Registration Routes		76
4.1 Fast Track Registration Routes		76
4.2 Regulatory Reliance		77
5. Manufacturing of Pharmaceuticals and Medical Devices		77
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		77
6. Distribution of Pharmaceuticals and Medical Devices		78
6.1 Wholesale of Pharmaceuticals and Medical Devices		78
6.2 Different Classifications Applicable to Pharmaceuticals		79
7. Import and Export of Pharmaceuticals and Medical Devices		79
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		79
7.2 Importer of Record of Pharmaceuticals and Medical Devices		80
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		80
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		80
7.5 Trade Blocs and Free Trade Agreements		81
8. Pharmaceutical and Medical Device Pricing and Reimbursement		81
8.1 Price Control for Pharmaceuticals and Medical Devices		81
8.2 Price Levels of Pharmaceuticals or Medical Devices		82
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		82
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		82
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		82
1. Life Sciences Regulatory Framework		98
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		98
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		98
1.3 Different Categories of Pharmaceuticals and Medical Devices		99
2. Clinical Trials		99
2.1 Regulation of Clinical Trials		99
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		100
2.3 Public Availability of the Conduct of a Clinical Trial		100
2.4 Restriction on Using Online Tools to Support Clinical Trials		101
2.5 Use of Data Resulting From Clinical Trials		101
2.6 Databases Containing Personal or Sensitive Data		102
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		102
3.1 Product Classification: Pharmaceuticals or Medical Devices		102
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		103
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		103
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		103
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		105
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		105
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		106
4. Regulatory Reliance and Fast Track Registration Routes		107
4.1 Fast Track Registration Routes		107
4.2 Regulatory Reliance		107
5. Manufacturing of Pharmaceuticals and Medical Devices		107
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		107
6. Distribution of Pharmaceuticals and Medical Devices		108
6.1 Wholesale of Pharmaceuticals and Medical Devices		108
6.2 Different Classifications Applicable to Pharmaceuticals		109
7. Import and Export of Pharmaceuticals and Medical Devices		109
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		109
7.2 Importer of Record of Pharmaceuticals and Medical Devices		109
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		109
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		110
7.5 Trade Blocs and Free Trade Agreements		110
8. Pharmaceutical and Medical Device Pricing and Reimbursement		110
8.1 Price Control for Pharmaceuticals and Medical Devices		110
8.2 Price Levels of Pharmaceuticals or Medical Devices		112
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		112
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		113
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		113
1. Life Sciences Regulatory Framework		123
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		123
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		124
1.3 Different Categories of Pharmaceuticals and Medical Devices		124
2. Clinical Trials		125
2.1 Regulation of Clinical Trials		125
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		125
2.3 Public Availability of the Conduct of a Clinical Trial		125
2.4 Restriction on Using Online Tools to Support Clinical Trials		126
2.5 Use of Data Resulting From Clinical Trials		126
2.6 Databases Containing Personal or Sensitive Data		126
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		127
3.1 Product Classification: Pharmaceuticals or Medical Devices		127
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		128
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		128
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		129
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		130
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		131
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		132
4. Regulatory Reliance and Fast Track Registration Routes		133
4.1 Fast Track Registration Routes		133
4.2 Regulatory Reliance		133
5. Manufacturing of Pharmaceuticals and Medical Devices		134
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		134
6. Distribution of Pharmaceuticals and Medical Devices		134
6.1 Wholesale of Pharmaceuticals and Medical Devices		134
6.2 Different Classifications Applicable to Pharmaceuticals		135
7. Import and Export of Pharmaceuticals and Medical Devices		136
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		136
7.2 Importer of Record of Pharmaceuticals and Medical Devices		136
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		137
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		138
7.5 Trade Blocs and Free Trade Agreements		139
8. Pharmaceutical and Medical Device Pricing and Reimbursement		139
8.1 Price Control for Pharmaceuticals and Medical Devices		139
8.2 Price Levels of Pharmaceuticals or Medical Devices		140
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		140
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		141
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		141
1. Life Sciences Regulatory Framework		152
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		152
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		153
1.3 Different Categories of Pharmaceuticals and Medical Devices		154
2. Clinical Trials		154
2.1 Regulation of Clinical Trials		154
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		154
2.3 Public Availability of the Conduct of a Clinical Trial		155
2.4 Restriction on Using Online Tools to Support Clinical Trials		155
2.5 Use of Data Resulting From Clinical Trials		155
2.6 Databases Containing Personal or Sensitive Data		156
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		156
3.1 Product Classification: Pharmaceuticals or Medical Devices		156
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		156
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		156
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		157
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		158
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		158
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		159
4. Regulatory Reliance and Fast Track Registration Routes		160
4.1 Fast Track Registration Routes		160
4.2 Regulatory Reliance		160
5. Manufacturing of Pharmaceuticals and Medical Devices		161
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		161
6. Distribution of Pharmaceuticals and Medical Devices		161
6.1 Wholesale of Pharmaceuticals and Medical Devices		161
6.2 Different Classifications Applicable to Pharmaceuticals		162
7. Import and Export of Pharmaceuticals and Medical Devices		162
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		162
7.2 Importer of Record of Pharmaceuticals and Medical Devices		162
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		162
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		163
7.5 Trade Blocs and Free Trade Agreements		163
8. Pharmaceutical and Medical Device Pricing and Reimbursement		163
8.1 Price Control for Pharmaceuticals and Medical Devices		163
8.2 Price Levels of Pharmaceuticals or Medical Devices		164
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		164
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		164
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		164
1. Life Sciences Regulatory Framework		170
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		170
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		170
1.3 Different Categories of Pharmaceuticals and Medical Devices		171
2. Clinical Trials		172
2.1 Regulation of Clinical Trials		172
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		172
2.3 Public Availability of the Conduct of a Clinical Trial		173
2.4 Restriction on Using Online Tools to Support Clinical Trials		173
2.5 Use of Data Resulting From Clinical Trials		173
2.6 Databases Containing Personal or Sensitive Data		174
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		174
3.1 Product Classification: Pharmaceuticals or Medical Devices		174
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		175
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		175
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		176
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		176
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		177
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		178
4. Regulatory Reliance and Fast Track Registration Routes		178
4.1 Fast Track Registration Routes		178
4.2 Regulatory Reliance		179
5. Manufacturing of Pharmaceuticals and Medical Devices		179
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		179
6. Distribution of Pharmaceuticals and Medical Devices		180
6.1 Wholesale of Pharmaceuticals and Medical Devices		180
6.2 Different Classifications Applicable to Pharmaceuticals		181
7. Import and Export of Pharmaceuticals and Medical Devices		181
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		181
7.2 Importer of Record of Pharmaceuticals and Medical Devices		181
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		181
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		182
7.5 Trade Blocs and Free Trade Agreements		182
8. Pharmaceutical and Medical Device Pricing and Reimbursement		182
8.1 Price Control for Pharmaceuticals and Medical Devices		182
8.2 Price Levels of Pharmaceuticals or Medical Devices		183
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		183
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		183
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		184
1. Life Sciences Regulatory Framework		188
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		188
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		188
1.3 Different Categories of Pharmaceuticals and Medical Devices		188
2. Clinical Trials		189
2.1 Regulation of Clinical Trials		189
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		190
2.3 Public Availability of the Conduct of a Clinical Trial		190
2.4 Restriction on Using Online Tools to Support Clinical Trials		190
2.5 Use of Data Resulting From Clinical Trials		190
2.6 Databases Containing Personal or Sensitive Data		190
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		191
3.1 Product Classification: Pharmaceuticals or Medical Devices		191
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		191
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		192
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		192
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		193
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		193
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		194
4. Regulatory Reliance and Fast Track Registration Routes		194
4.1 Fast Track Registration Routes		194
4.2 Regulatory Reliance		194
5. Manufacturing of Pharmaceuticals and Medical Devices		195
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		195
6. Distribution of Pharmaceuticals and Medical Devices		195
6.1 Wholesale of Pharmaceuticals and Medical Devices		195
6.2 Different Classifications Applicable to Pharmaceuticals		195
7. Import and Export of Pharmaceuticals and Medical Devices		196
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		196
7.2 Importer of Record of Pharmaceuticals and Medical Devices		196
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		196
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		196
7.5 Trade Blocs and Free Trade Agreements		197
8. Pharmaceutical and Medical Device Pricing and Reimbursement		197
8.1 Price Control for Pharmaceuticals and Medical Devices		197
8.2 Price Levels of Pharmaceuticals or Medical Devices		197
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		198
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		198
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		198
1. Life Sciences Regulatory Framework		203
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		203
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		203
1.3 Different Categories of Pharmaceuticals and Medical Devices		204
2. Clinical Trials		205
2.1 Regulation of Clinical Trials		205
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		206
2.3 Public Availability of the Conduct of a Clinical Trial		206
2.4 Restriction on Using Online Tools to Support Clinical Trials		206
2.5 Use of Data Resulting From Clinical Trials		207
2.6 Databases Containing Personal or Sensitive Data		207
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		207
3.1 Product Classification: Pharmaceuticals or Medical Devices		207
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		208
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		208
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		208
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		210
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		210
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		211
4. Regulatory Reliance and Fast Track Registration Routes		211
4.1 Fast Track Registration Routes		211
4.2 Regulatory Reliance		212
5. Manufacturing of Pharmaceuticals and Medical Devices		212
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		212
6. Distribution of Pharmaceuticals and Medical Devices		213
6.1 Wholesale of Pharmaceuticals and Medical Devices		213
6.2 Different Classifications Applicable to Pharmaceuticals		213
7. Import and Export of Pharmaceuticals and Medical Devices		213
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		213
7.2 Importer of Record of Pharmaceuticals and Medical Devices		214
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		214
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		214
7.5 Trade Blocs and Free Trade Agreements		215
8. Pharmaceutical and Medical Device Pricing and Reimbursement		215
8.1 Price Control for Pharmaceuticals and Medical Devices		215
8.2 Price Levels of Pharmaceuticals or Medical Devices		216
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		216
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		217
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		217
1. Life Sciences Regulatory Framework		240
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		240
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		240
1.3 Different Categories of Pharmaceuticals and Medical Devices		240
2. Clinical Trials		240
2.1 Regulation of Clinical Trials		240
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		241
2.3 Public Availability of the Conduct of a Clinical Trial		241
2.4 Restriction on Using Online Tools to Support Clinical Trials		241
2.5 Use of Data Resulting From Clinical Trials		241
2.6 Databases Containing Personal or Sensitive Data		242
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		242
3.1 Product Classification: Pharmaceuticals or Medical Devices		242
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		242
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		242
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		243
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		243
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		243
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		244
4. Regulatory Reliance and Fast Track Registration Routes		244
4.1 Fast Track Registration Routes		244
4.2 Regulatory Reliance		244
5. Manufacturing of Pharmaceuticals and Medical Devices		244
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		244
6. Distribution of Pharmaceuticals and Medical Devices		245
6.1 Wholesale of Pharmaceuticals and Medical Devices		245
6.2 Different Classifications Applicable to Pharmaceuticals		245
7. Import and Export of Pharmaceuticals and Medical Devices		245
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		245
7.2 Importer of Record of Pharmaceuticals and Medical Devices		245
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		245
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		245
7.5 Trade Blocs and Free Trade Agreements		246
8. Pharmaceutical and Medical Device Pricing and Reimbursement		246
8.1 Price Control for Pharmaceuticals and Medical Devices		246
8.2 Price Levels of Pharmaceuticals or Medical Devices		246
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		247
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		247
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		247
1. Life Sciences Regulatory Framework		259
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		259
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		259
1.3 Different Categories of Pharmaceuticals and Medical Devices		260
2. Clinical Trials		260
2.1 Regulation of Clinical Trials		260
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		261
2.3 Public Availability of the Conduct of a Clinical Trial		261
2.4 Restriction on Using Online Tools to Support Clinical Trials		261
2.5 Use of Data Resulting From Clinical Trials		262
2.6 Databases Containing Personal or Sensitive Data		262
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		262
3.1 Product Classification: Pharmaceuticals or Medical Devices		262
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		263
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		263
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		264
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		265
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		266
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		266
4. Regulatory Reliance and Fast Track Registration Routes		267
4.1 Fast Track Registration Routes		267
4.2 Regulatory Reliance		268
5. Manufacturing of Pharmaceuticals and Medical Devices		269
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		269
6. Distribution of Pharmaceuticals and Medical Devices		270
6.1 Wholesale of Pharmaceuticals and Medical Devices		270
6.2 Different Classifications Applicable to Pharmaceuticals		270
7. Import and Export of Pharmaceuticals and Medical Devices		270
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		270
7.2 Importer of Record of Pharmaceuticals and Medical Devices		271
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		271
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		272
7.5 Trade Blocs and Free Trade Agreements		272
8. Pharmaceutical and Medical Device Pricing and Reimbursement		272
8.1 Price Control for Pharmaceuticals and Medical Devices		272
8.2 Price Levels of Pharmaceuticals or Medical Devices		272
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		273
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		273
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		273
1. Life Sciences Regulatory Framework		284
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		284
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		284
1.3 Different Categories of Pharmaceuticals and Medical Devices		284
2. Clinical Trials		285
2.1 Regulation of Clinical Trials		285
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		285
2.3 Public Availability of the Conduct of a Clinical Trial		285
2.4 Restriction on Using Online Tools to Support Clinical Trials		286
2.5 Use of Data Resulting From Clinical Trials		286
2.6 Databases Containing Personal or Sensitive Data		286
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		286
3.1 Product Classification: Pharmaceuticals or Medical Devices		286
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		287
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		287
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		288
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		288
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		288
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		289
4. Regulatory Reliance and Fast Track Registration Routes		289
4.1 Fast Track Registration Routes		289
4.2 Regulatory Reliance		290
5. Manufacturing of Pharmaceuticals and Medical Devices		291
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		291
6. Distribution of Pharmaceuticals and Medical Devices		291
6.1 Wholesale of Pharmaceuticals and Medical Devices		291
6.2 Different Classifications Applicable to Pharmaceuticals		291
7. Import and Export of Pharmaceuticals and Medical Devices		292
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		292
7.2 Importer of Record of Pharmaceuticals and Medical Devices		293
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		293
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		293
7.5 Trade Blocs and Free Trade Agreements		293
8. Pharmaceutical and Medical Device Pricing and Reimbursement		293
8.1 Price Control for Pharmaceuticals and Medical Devices		293
8.2 Price Levels of Pharmaceuticals or Medical Devices		294
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		294
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		295
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		295
1. Life Sciences Regulatory Framework		306
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		306
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		308
1.3 Different Categories of Pharmaceuticals and Medical Devices		308
2. Clinical Trials		308
2.1 Regulation of Clinical Trials		308
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		308
2.3 Public Availability of the Conduct of a Clinical Trial		309
2.4 Restriction on Using Online Tools to Support Clinical Trials		309
2.5 Use of Data Resulting From Clinical Trials		310
2.6 Databases Containing Personal or Sensitive Data		310
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		310
3.1 Product Classification: Pharmaceuticals or Medical Devices		310
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		311
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		311
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		312
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		313
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		314
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		314
4. Regulatory Reliance and Fast Track Registration Routes		316
4.1 Fast Track Registration Routes		316
4.2 Regulatory Reliance		316
5. Manufacturing of Pharmaceuticals and Medical Devices		316
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		316
6. Distribution of Pharmaceuticals and Medical Devices		317
6.1 Wholesale of Pharmaceuticals and Medical Devices		317
6.2 Different Classifications Applicable to Pharmaceuticals		318
7. Import and Export of Pharmaceuticals and Medical Devices		318
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		318
7.2 Importer of Record of Pharmaceuticals and Medical Devices		319
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		319
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		319
7.5 Trade Blocs and Free Trade Agreements		319
8. Pharmaceutical and Medical Device Pricing and Reimbursement		320
8.1 Price Control for Pharmaceuticals and Medical Devices		320
8.2 Price Levels of Pharmaceuticals or Medical Devices		320
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		321
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		322
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		323
1. Life Sciences Regulatory Framework		334
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		334
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		334
1.3 Different Categories of Pharmaceuticals and Medical Devices		334
2. Clinical Trials		335
2.1 Regulation of Clinical Trials		335
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		336
2.3 Public Availability of the Conduct of a Clinical Trial		336
2.4 Restriction on Using Online Tools to Support Clinical Trials		337
2.5 Use of Data Resulting From Clinical Trials		337
2.6 Databases Containing Personal or Sensitive Data		337
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		337
3.1 Product Classification: Pharmaceuticals or Medical Devices		337
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		338
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		338
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		338
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		339
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		340
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		341
4. Regulatory Reliance and Fast Track Registration Routes		341
4.1 Fast Track Registration Routes		341
4.2 Regulatory Reliance		342
5. Manufacturing of Pharmaceuticals and Medical Devices		344
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		344
6. Distribution of Pharmaceuticals and Medical Devices		344
6.1 Wholesale of Pharmaceuticals and Medical Devices		344
6.2 Different Classifications Applicable to Pharmaceuticals		345
7. Import and Export of Pharmaceuticals and Medical Devices		345
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		345
7.2 Importer of Record of Pharmaceuticals and Medical Devices		345
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		345
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		346
7.5 Trade Blocs and Free Trade Agreements		346
8. Pharmaceutical and Medical Device Pricing and Reimbursement		346
8.1 Price Control for Pharmaceuticals and Medical Devices		346
8.2 Price Levels of Pharmaceuticals or Medical Devices		347
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		347
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		347
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		348
1. Life Sciences Regulatory Framework		361
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		361
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		361
1.3 Different Categories of Pharmaceuticals and Medical Devices		362
2. Clinical Trials		362
2.1 Regulation of Clinical Trials		362
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		363
2.3 Public Availability of the Conduct of a Clinical Trial		363
2.4 Restriction on Using Online Tools to Support Clinical Trials		364
2.5 Use of Data Resulting From Clinical Trials		364
2.6 Databases Containing Personal or Sensitive Data		364
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		364
3.1 Product Classification: Pharmaceuticals or Medical Devices		364
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		365
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		365
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		366
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		367
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		367
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		368
4. Regulatory Reliance and Fast Track Registration Routes		368
4.1 Fast Track Registration Routes		368
4.2 Regulatory Reliance		369
5. Manufacturing of Pharmaceuticals and Medical Devices		370
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		370
6. Distribution of Pharmaceuticals and Medical Devices		370
6.1 Wholesale of Pharmaceuticals and Medical Devices		370
6.2 Different Classifications Applicable to Pharmaceuticals		370
7. Import and Export of Pharmaceuticals and Medical Devices		371
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		371
7.2 Importer of Record of Pharmaceuticals and Medical Devices		371
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		371
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		371
7.5 Trade Blocs and Free Trade Agreements		371
8. Pharmaceutical and Medical Device Pricing and Reimbursement		372
8.1 Price Control for Pharmaceuticals and Medical Devices		372
8.2 Price Levels of Pharmaceuticals or Medical Devices		373
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		373
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		374
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		374
1. Life Sciences Regulatory Framework		379
1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices		379
1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation		380
1.3 Different Categories of Pharmaceuticals and Medical Devices		380
2. Clinical Trials		381
2.1 Regulation of Clinical Trials		381
2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial		381
2.3 Public Availability of the Conduct of a Clinical Trial		381
2.4 Restriction on Using Online Tools to Support Clinical Trials		381
2.5 Use of Data Resulting From Clinical Trials		381
2.6 Databases Containing Personal or Sensitive Data		382
3. Marketing Authorisations for Pharmaceuticals or Medical Devices		382
3.1 Product Classification: Pharmaceuticals or Medical Devices		382
3.2 Granting a Marketing Authorisation for Biologic Medicinal Products		382
3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices		382
3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices		382
3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations		383
3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations		383
3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices		383
4. Regulatory Reliance and Fast Track Registration Routes		384
4.1 Fast Track Registration Routes		384
4.2 Regulatory Reliance		384
5. Manufacturing of Pharmaceuticals and Medical Devices		385
5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices		385
6. Distribution of Pharmaceuticals and Medical Devices		385
6.1 Wholesale of Pharmaceuticals and Medical Devices		385
6.2 Different Classifications Applicable to Pharmaceuticals		385
7. Import and Export of Pharmaceuticals and Medical Devices		385
7.1 Governing Law for the Import and Export of Pharmaceuticals and Medical Devices and Relevant Enforcement Bodies		385
7.2 Importer of Record of Pharmaceuticals and Medical Devices		386
7.3 Prior Authorisations for the Import of Pharmaceuticals and Medical Devices		386
7.4 Non-Tariff Regulations and Restrictions Imposed Upon Imports		386
7.5 Trade Blocs and Free Trade Agreements		387
8. Pharmaceutical and Medical Device Pricing and Reimbursement		387
8.1 Price Control for Pharmaceuticals and Medical Devices		387
8.2 Price Levels of Pharmaceuticals or Medical Devices		388
8.3 Pharmaceuticals and Medical Devices: Reimbursement From Public Funds		388
8.4 Cost-Benefit Analyses for Pharmaceuticals and Medical Devices		388
8.5 Regulation of Prescriptions and Dispensing by Pharmacies		389

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