Quality requirements
In order to support the quality of the drug, the applicant has to provide the drug master file for new chemical entity, first generic drugs, and generics drugs for life-saving and serious illnesses, such as cancer, cardiovascular diseases and antibiotic drugs. Also, on-site evaluation at the facility of product manufacturer is done to ensure the validity of information written in documents of quality.

Crietria for imported drugs
Imported drugs are limited to drugs for public health program, new innovated drugs that are under patent protection and drugs that are needed but not feasible to be produced locally.

It covers manufacturing technology and facility not available in Indonesia, manufacturing capacities insufficient to fulfil national need, economically not feasible production in Indonesia due to low need and produced through centralized system by foreign pharmaceutical industry which has investments in Indonesia, supported by balance of import and export activity.

Applicant pharmaceutical companies in Indonesia need to have written authorization from the manufacturer abroad. Manufacturers need to have manufacturing licenses and meetGMP requirements as proven by valid GMP certificate and also carry data of the last inspection within the last two years of application. Applicant has to submit latest master file documents if the manufacturer has not had any product with the same dosage form authorized to be marketed in Indonesia and if the manufacturer has product with the same dosage form authorized to be marketed in Indonesia, but there is a change of production facilities. Moreover, if site master file evaluation result requires evidence of compliance to GMP, then site inspection will be conducted.

(As shared by Ms Endang Woro Tedjowati, director, Drug and Biological Product Evaluation, NADFC-Indonesia, during the 'Pharmaceutical Regulatory Summit 'held in Singapore during August 2012. To know more about regulatory-related issues in Indonesia, visit www.pom.go.id)