• SL keen to adopt certain FDA regulatory practices

A team of specialists from the United States (US) Food and Drug Administration (FDA) kicked off a three-day programme yesterday (30) aimed at familiarising the members of the National Medicines Regulatory Authority (NMRA) with the standards, quality control and medicine regulatory system used by the US, The Daily Morning learns.

According to the NMRA, the programme included about 50 NMRA staffers, including pharmaceutical assessors, and analysts. The programme will conclude with a field visit to a pharmaceutical manufacturing plant, where compliance will be analysed.  The three-member team of FDA specialists had arrived in Sri Lanka following an invitation from the Government, it is learnt.

The move, according to the NMRA, is aimed at capacity building and allowing Sri Lankan regulators to upskill. It is learnt that the NMRA is also keen to identify world class regulatory practices which the FDA employs to improve Sri Lanka’s troubled pharmaceutical regulatory system and quality control measures.   

“This is an opportunity for us to share their (US FDA) drug regulations, evaluation and industry regulation methodologies. This is also a capacity building exercise. Last month (July), when we had a discussion with senior Government officials regarding the ongoing situation, the President directed us (NMRA) to benchmark the FDA regulatory process. So, this programme is a result of that process,” the Director General and Chief Executive Officer of the NMRA, Dr. Vijith Gunasekera told The Daily Morning.

The FDA team of specialists is comprised of the Country Director – FDA India, Dr Sarah McMullen, the Senior Assistant Country Director and International Relations Specialist - FDA India, Dr Phuc Nguyen, and the Senior Technical Advisor - FDA India, Dr Sudhindra Kulkarni.