All drug products which will be marketed in Indonesia shall be registered to National Agency of Drug and Food Control (NADFC – or locally known as BPOM). Before BPOM issued Marketing Authorization for drug products, BPOM will perform Pre-Market Control to assess the efficacy, safety and quality of the drug product. The validity of Marketing Authorization will lasts normally for 5 years, except for License Manufacturing or Contract Manufacturing which can be different depending on the agreement validity.
Drug Registration in Indonesia consists of 3 different kind of registrations which divided into 7 categories, under Article 5 of BPOM Regulation No 3:New Drug Registration : for new drug which do not have Marketing Authorization Category 1: Registration for New Drug and Biological Product, including Similar Biotherapeutic Product (SBP) Category 2 : Registration of Copy Drug Category 3: Registration of other supplies which contain drug Variation Registration : Registration of change in any aspect of a registered drug which has Marketing Authorization Category 4: Major Variation (VaMa) Category 5: Minor variation with approval (VaMi-B) Category 6: Minor Variation with notification (VaMi-A) Re-registration : Renewal or extension of Marketing Authorization period, and this is considered as Category 7
This article will be focus on Category 1 Drug Registration of New Drug Product, including:Type of Drug Product, New Drug Application Procedure, including Registration Document which need to be prepared Drug Evaluation Procedure Reliance Mechanism Criteria and Required Documents for Imported Drug Registration
Type of Product
There are 2 types of drug product that can be registered in Indonesia:Domestic Manufactured Drug which can be obtained from own manufacturing, license manufacturing, or contract manufacturing Imported Drug (either Bulk product or Finished product) …