Impact of Decision to Decline FDA Inspections of Factories Outside the US on Generic Medications in Singapore

Mr Chong Kee Hiong asked the Minister for Health with regard to declining FDA inspections of factories outside of the US where much of the active ingredients for generic pharmaceuticals are manufactured (a) what is the impact on generic medications in Singapore; (b) how reliant is Singapore on FDA assessments and whether Singapore can have independent local inspections of medications; (c) what additional measures are in place to protect the quality of medications; and (d) how will the Ministry work with international health agencies to overcome this structural inspection problem.

The Health Sciences Authority (HSA) evaluates medicines, including generics, for safety, quality and efficacy before as well as after they are registered and allowed for supply in our local market.

Before giving approval for registration, HSA inspects local medicines manufacturers to ensure that they comply with international Good Manufacturing Practice (GMP) standards. As for assessing manufacturers based overseas, HSA taps on its membership in the Pharmaceutical Inspection Co-operation Scheme. Membership to the scheme is granted only if a regulator has a strict inspection regime comparable with the high standards and quality of the other members. Some members in the scheme include regulators from Australia, Canada, Germany, Japan, Switzerland and the US.

If a member regulatory authority has inspected the overseas medicines manufacturers, HSA would leverage on their findings on the GMP assessment. Otherwise, HSA will conduct an overseas on-site inspection.

After a medicine is registered and sold in the Singapore market, inspections of manufacturers continue to be conducted on a regular basis. HSA also carries out post-market product quality sampling to test and ensure that the medicines comply with quality requirements and are safe for use by patients. In addition, HSA exchanges information and intelligence with other leading international regulatory authorities on the quality of the medicines, including generics.