Updated on 16 October 2012
Are pharma firms facing regulatory hurdles in Indonesia?
The lifesciences industry in the Asia Pacific (APAC) region offers huge opportunities for companies, which are looking for growth. Regulatory approvals often act as hurdles for these firms in the APAC region. BioSpectrum speaks to individuals from the industry and regulatory professionals from Indonesia, in order to compile a guide on the regulatory processes in the country. (Also read during this week: Regulatory requirements in China, Taiwan, Australia, Hong Kong, India, Singapore and Korea)
In Indonesia the National Agency of Drug and Food Control (NA-DFC) is responsible for regulating pharmaceuticals products and drugs in Indonesia. Primary functions of NA-DFC include pre-market evaluation of medical products, legislation, regulation, standardization, and GMP certification.
The criteria and guidelines for registration in Indonesia were last updated in 2011. It is based on assessment of the drug's risk, quality, safety and efficacy and need of people. The drug registration application in Indonesia can only be done by pharmaceutical companies located in Indonesia through a pre-registration process, which takes around 40 working days. It involves consultation on completeness of registration dossier and document and registration fees.
Another important organization that plays a key role in the regulatory processes in
Indonesia is the National Committee on Drug Evaluation. It consists of experts in the field of clinical pharmacology, pharmacy, biology and relevant clinicians recruited from universities and other relevant institutions.
Timeline for evaluation
It takes 40 working days for export-only products and for minor variation that need approval from the authority. It takes 100 working days for life-saving drugs, orphan drugs, drugs for national program, drug development and all clinical trials in Indonesia, and copy drugs with electronic standardized information.