USA
Canada
United States of America
Washington DC
Law and Practice Contributed by: Daniel Kracov, David Marsh and Alice Ho Arnold & Porter
Mexico
Contents 1. Life Sciences Regulatory Framework p.378 1.1 Legislation and Regulation for Pharmaceuticals and Medical Devices p.378 1.2 Challenging Decisions of Regulatory Bodies That Enforce Pharmaceuticals and Medical Devices Regulation p.379 1.3 Different Categories of Pharmaceuticals and Medical Devices p.379 2. Clinical Trials p.380 2.1 Regulation of Clinical Trials p.380 2.2 Procedure for Securing Authorisation to Undertake a Clinical Trial p.380 2.3 Public Availability of the Conduct of a Clinical Trial p.380 2.4 Restriction on Using Online Tools to Support Clinical Trials p.380 2.5 Use of Data Resulting From Clinical Trials p.380 2.6 Databases Containing Personal or Sensitive Data p.381 3. Marketing Authorisations for Pharmaceuticals or Medical Devices p.381 3.3 Period of Validity for Marketing Authorisation for Pharmaceuticals or Medical Devices p.381 3.4 Procedure for Obtaining a Marketing Authorisation for Pharmaceuticals and Medical Devices p.381 3.5 Access to Pharmaceuticals and Medical Devices Without Marketing Authorisations p.382 3.6 Marketing Authorisations for Pharmaceuticals and Medical Devices: Ongoing Obligations p.382 3.7 Third-Party Access to Pending Applications for Marketing Authorisations for Pharmaceuticals and Medical Devices p.382 4. Regulatory Reliance and Fast Track Registration Routes p.383 4.1 Fast Track Registration Routes p.383 4.2 Regulatory Reliance p.383 5. Manufacturing of Pharmaceuticals and Medical Devices p.384 5.1 Requirement for Authorisation for Manufacturing Plants of Pharmaceuticals and Medical Devices p.384 6. Distribution of Pharmaceuticals and Medical Devices p.384 6.1 Wholesale of Pharmaceuticals and Medical Devices p.384 3.1 Product Classification: Pharmaceuticals or Medical Devices p.381 3.2 Granting a Marketing Authorisation for Biologic Medicinal Products p.381
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