South-East Asia Regulatory Network (SEARN)
3rd Annual meeting of the South-East Asia Regulatory Network (SEARN), New Delhi, 24 – 25 April 2019
Photos from the Annual Meeting of the SEARN, 21 – 23 March 2018, Colombo, Sri Lanka.
The National Medicines Regulatory Authority (NMRA) as the representative institution in the country,acting as the domestic national regulatory authority,had their representatives participating in the SEA Regional Training Workshop to use the WHO New Benchmarking Tool to Strengthen National Regulatory Systems, in Jakarta, Indonesia in June 2017.
Using these learnings, the NMRA subsequently conducted a self-benchmarking of their regulatory system using WHO Global Benchmarking Tool indicators. A WHO mission was invited in February 2018 to review all indicators with NMRA responsible of each regulatory function.
Subsiquently, two training priorities were identified on Good Manufacturing Practices (GMP) and on Pharmacovigilance to be implemented during the first quarter 2019. The WHO was to support and facilitate the training of NMRA inspectors on GMP to acquire the principals of BASIC GMP not only for the enforcement in the domestic pharmaceutical industry but also when conducting GMP inspections in manufacturing facility in foreign countries. The training material used for the workshop was developed by WHO with the collaboration of NRA GMP experts from LMIC.
The workshop was held in Colombo in December 2018. The participants for the workshop comprised of regulatory inspectors who are involved in inspections of medicine manufacturers. 3 participants from Nepal Authority and 10 observers from Local Pharmaceutical Manufacturers’ also participated.
The workshop was conducted for a period of 5 days with top experts from WHO as it’s facilitators. The workshop resulted in regulatory inspectors responsible for vaccine and medicine manufacturers GMP compliance improving and updating their knowledge on GMP requirements that enabled them to better understand the different levels of GMP to produce pharmaceutical, vaccine and biologicals, the GMP certification process and documentation, WHO GMP principal for pharmaceutical, the Prequalification and the role of PICS and other regional regulatory networks and in improving their skills in conducting GMP inspections.