Updated on 16 October 2012
It takes 150 working days for drugs that have been marketed in countries which have implemented harmonized evaluation system, for new indications which have been marketed in the countries that have implemented harmonized evaluation system and copy drugs without electronic standardized system.
Furthermore, it takes 300 working days for new drugs, biological products and similar biotherapeutic products not included in the list of 100 working days and 150 working days.
Criteria of drug evaluation
Drugs are evaluated in Indonesia based on risk assessment. Efficacy and safety of non-clinical studies and clinical studies for phase I, II , III need to be established. Quality is assessed in manufacturing process according to GMP, product specification, stability study and bioequivalent study for generic products and product information and labelling information need to be correct and ensure rational use of drug.
Review of a pharmaceutical product involves its safety and efficacy aspect. It should be scientific and evidence-based, demonstrating compliance in preclinical studies, product development and clinical protocol design. It also involves the quality aspect where standardization and control on specification and method of analysis of active ingredient and finished products is done.
Moreover, there should be control on production process and it should follow good manufacturing practises that ensure safety and consistency. Promotion and labelling of the product need to be done according to the approved product information rational.