Strengthening Post-Market Surveillance in Indonesia


The Challenge

Comprehensive and effective policies are fundamental to ensuring a well-functioning medicines regulatory authority, a vital part of a country’s overall health system.

In Indonesia, PQM advocated for revision of regulation (or ‘menkes’ in the Bahasa language) Menkes 2/2016 to strengthen quality assurance and post-marketing surveillance components.

Our Strategy

Throughout the year, PQM contributed to the regulation’s revision through advocacy and technical assistance efforts. During third quarter, PQM conducted two seminational workshops convening officials from the Indonesian Ministry of Health and medicines regulatory authority for extensive discussion on additional provisions to Menkes 2/2016.


Based on the outcome of these two workshops, during the fourth quarter, Menkes 2/2016 was revised to Menkes 33/2016, which now includes the additional quality assurance provisions.

The Menkes 33/2016 regulation is one of PQM’s greatest achievements in Indonesia to date in terms of the policy’s importance, reach, and longevity. The revision incorporates stronger medicines quality assurance components that the previous regulation lacked. Menkes 33/2016 ensures proper coordination between the Ministry of Health and regulatory authority on medicines that are tested through post-marketing surveillance. The revision was signed into action to include important medicines quality assurance provisions.