WHO, Indonesian FDA increase access to safe and effective medicines

The World Health Organization (WHO) and Indonesian Food and Drug Authority (BPOM) have in recent months taken targeted action to increase access to safe and effective medicines and medical products, with a focus on strengthening pharmacovigilance and good distribution practices. 

Pharmacovigilance refers to the science and systems used to detect, assess, understand and prevent adverse effects or any other drug-related problem. Good distribution practices (GDP) refer to the practices and systems used to ensure the quality, safety and efficacy of a finished medicine or medical product delivered to market. Both are critical to ensure access for all to safe, effective, quality and affordable essential medicines and medical products, and to achieve universal health coverage (UHC), in alignment with Indonesia’s health transformation agenda.  

At a workshop in June 2023, WHO and BPOM Directorate of Safety, Quality and Export-Import Control of Drugs, Narcotics, Psychotropics, Precursors and Addictive Substances helped build the capacity of 162 pharmacovigilance evaluators from BPOM central and regional offices. The workshop covered a range of key topics, including pharmacovigilance reports analysis and safety signal detection and assessment. 

At a workshop in September 2023, WHO and BPOM Directorate of Distribution Control of Drugs, Narcotics, Psychotropics, Precursors and Addictive Substances helped improve the skills of 43 regional BPOM officers in GDP inspection, regulation and communication, with a focus on pharmaceutical distribution and service facilities. The training increased the BPOM inspector workforce by 10%.  

And at a workshop in October 2023, WHO and BPOM Directorate of Drug Registration helped enhance the ability of 170 BPOM officers and industry stakeholders to conduct Risk Management Plan preparation, development and evaluation as part of pre-market evaluation. 

Together, the workshops were supported by the Medical Dictionary for Regulatory Activities Maintenance and Support Services Organization and the Therapeutic Goods Administration of Australia.

“Access to safe, effective, quality and affordable medicines and medical products is a right, not a privilege,” said WHO Representative to Indonesia, Dr N. Paranietharan. “But it is also an operational imperative, critical to achieving UHC and Health for All, and delivering on Indonesia’s national health transformation agenda.”

“In the months and years ahead, WHO will continue to support the Ministry of Health and BPOM in this critical area of work, in alignment with national priorities, and drawing on the tremendous progress already achieved.” 

In 2024, WHO will work with the Ministry of Health and BPOM to develop a pharmacovigilance curriculum for medical and pharmacy students; create a pharmacovigilance coordination team; and carry out a series of GDP inspector trainings for senior level inspectors, ensuring that progress is rapid and sustained, and that it continues to benefit every Indonesian, everywhere.