Part I, Section A: Product Particulars

Please refer Glossary developed for the ACTD and ACTR. The definitions used in the glossary have been developed for the ASEAN Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR). They are not necessarily meaningful outside the scope of the specific parts of ACTD and ACTR to which they refer.

Other References:

  1. New Product Development Requisition (NPDR)
  2. Innovator’s immediate label, outer carton & package insert
  3. Product Development Report (PDR)
  4. Martindale/AHFS/electronic Medicines Compendium (eMC) –
  5. Information from other available registered products in Malaysia
A1 - A3
Details of the following as entered under Product Validation will appear automatically in the application form:

1. Product name; 
2. Name and Strength of Active Ingredients, Name and Strength of Excipients; and
3. Dosage form.

  • Please specify the form of product dosing such as: tablet, capsule, suspension, cream, ointment, granule or other dose form.
  • Please state the source of gelatin coating capsules used, for example: Porcine, Bovine or vegi cap.
  • Please submit certificate of analysis (COA) for capsule coating that state the source of gelatin.
  • Sources of bovine should be declared free from 'BSE / Mad cow disease & TSE'.
  • Please ensure the type of coloring agent used should be stated and is the only one allowed not prohibited.
  • Please refer to Appendix 18 Lists of Permitted and Restricted Colouring Agents in the DRGD for information change from time to time.
A4 : Product Description
A5 : Pharmacodynamic
A6 : Pharmacokinetics
A7 : Indication
A8 : Recommended Dose
A9 : Route of Administration
A10 : Contraindication
A11 : Warning and Precautions
A12 : Interaction with Other Medicaments
A13 : Pregnancy and Lactation
A14 : Side Effects
A15 : Symptoms & Treatment of Overdose
A16 : Effect on Ability to Drive and Use Machine
A17 : Preclinical Safety Data
A18 : Instructions For Use
A19 : Storage Condition
A20 : Shelf life
A21 : Therapeutical Code/ATC Code (If any)
A22 : Herbal Code (If any)

National Pharmaceutical Regulatory Agency (NPRA)

Lot 36, Jalan Universiti (Jalan Prof Diraja Ungku Aziz), 46200 Petaling Jaya, Selangor, Malaysia.

  • Phone: +603-7883 5400



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