Drug Registration Guidance Document (DRGD) Latest Edition

  • This “DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD)” will serve as the reference guide for the registration process including quality control, inspection & licensing and post-registration activities of medicinal products.
  • This DRGD shall be read in conjunction with the current laws and regulations together with other relevant legislations, where applicable, governing pharmaceutical and natural products for human use in Malaysia, which include but are not limited to the following:
  1. Sale of Drugs Act 1952;
  2. Control of Drugs and Cosmetics Regulations 1984;
  3. Dangerous Drugs Act 1952;
  4. Poisons Act 1952;
  5. Medicines (Advertisement & Sale) Act 1956;
  6. Wildlife Conservation Act 2010 (Laws of Malaysia Act 716); and
  7. International Trade in Endangered Species Act 2008 (Act 686).
  • The written laws shall take precedence over this guidance document in any event of discrepancy.

View Drug Registration Guidance Document (DRGD) Main Page

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