SINGAPORE Law and Practice Contributed by: Tony Yeo and Benjamin Gaw, Drew & Napier LLC
2.6 Personal or Sensitive Data The creation of a database containing personal or sensitive data would not be subject to requirements beyond those already set out in the PDPA.
whether alone or in combination, for humans for one or more of the following specific purposes: • diagnosis, prevention, monitoring, treatment or alleviation of disease; • diagnosis, monitoring, treatment or alleviation of, or compensation for, an injury; • investigation, replacement, modification or sup- port of the anatomy or of a physiological process, • providing information by means of in vitro examina- tion of specimens derived from the human body, for medical or diagnostic purpose. Medical devices must not achieve their primary intended action in or on the human body by phar- macological, immunological or metabolic means, but may be assisted in their intended function by such means. Medical devices also include: • any implant for the modification or fixation of any body part; • any injectable dermal filler or mucous membrane filler; or • any instrument, apparatus, implement, machine or appliance intended to be used for the removal or degradation of fat by invasive means. 3.2 Marketing Authorisation for Biologic Medicinal Products mainly for medical purposes; • supporting or sustaining life; • control of conception; • disinfection of medical devices; or Biologic medicinal products are generally classified as therapeutic products and are not subject to any specific obligations in relation to the granting of a mar- keting authorisation. Biosimilars are “follow-on” versions of biologic medic- inal products and are required to be submitted under a new drug application, rather than a generic drug application. The registration of biosimilar products involves a comprehensive comparability exercise, where similarity to an existing biologic medicinal product registered in Singapore in terms of physico-
3. Marketing Authorisations 3.1 Product Classification
The classification of a health product is assessed when an application for registration is screened to determine whether it should be accepted for evalu- ation. Therapeutic Products A therapeutic product is any substance that is intend- ed for use by and in humans for any of the following purposes: • preventing, diagnosing, monitoring, treating, curing or alleviating any disease, disorder, ailment, injury, handicap or abnormal physical or mental state, or any symptom thereof; • investigating, modifying or replacing any physi- ological process; • influencing, controlling or preventing conception; or • inducing anaesthesia. A therapeutic product must have any of the following active ingredients as a constituent: • any chemical or botanical element, naturally occur- ring chemical or botanical material, or chemical product obtained by chemical change or synthesis; • any metabolite from a micro‑organism; • any macromolecule extracted from an organism; or • any substance derived from a biological system. A therapeutic product must also exert an inherent effect either pharmacologically, chemically or by other physiological means, leading to its use for a thera- peutic, preventative, palliative or diagnostic purpose. Medical Devices A medical device is any instrument, apparatus, imple- ment, machine, appliance, implant, reagent for in vitro use, software, material or other similar or related arti - cle that is intended by its manufacturer to be used,
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