USA — The U.S. FDA has signed an agreement with Switzerland that will allow each country to rely on the “other’s good manufacturing practice inspections of pharmaceutical manufacturing facilities, avoiding the need for duplicate inspections.”

The agreement is the result of a multi-year negotiation between the two countries.

The agreement on mutual recognition between the Swiss Confederation and the U.S. relating pharmaceutical good manufacturing practice will help the country’s two regulatory agencies, the U.S. FDA and Swissmedic become more efficient and expand their international reach.

The agreement signed by the FDA, Swissmedic, the Office of the U.S. Trade Representative, and Switzerland’s State Secretariat for Economic Affairs, will cover facilities making human and veterinary drugs.

The 2012 Food and Drug Administration Safety and Innovation Act granted FDA the authority to enter into such agreements, and it already has separate agreements in place with the European Union (EU) and the United Kingdom.

The EU and the US import a large portion of their Active Pharmaceutical Ingredients (APIs) and finished pharmaceuticals from countries other than the U.S.

The agreement allows both sides’ inspection agencies to direct their resources toward facilities that supply these APIs and finished pharmaceuticals, and as a result of increased inspections, adequate levels of controls are implemented to improve product quality and safety.

The Food and Drug Administration Safety and Innovation Act, enacted in 2012, permits the FDA to enter into agreements to recognize drug inspections conducted by foreign regulatory authorities determined to be capable of conducting inspections that meet U.S. requirements.

With the Mutual Recognition Agreement (MRA) signed, it’s a sigh of relief to drug manufacturers. Many manufacturing facilities on both sides will see fewer inspections, and hardly will companies see duplicate FDA, EMA, Swissmedic, and GMP Inspections.

Post the MRA, drug manufacturers stand to benefit from the improved communication of actions that result in drug shortages, product recalls, counterfeits, and defects.

The US-compliant, and now the Swissmedic-compliant companies will be enabled faster access to mutual markets and other countries that depended on the inspections of the FDA and Swissmedic.

Europe and the United States account for more than 80% of global sales of new medicines. However, a large proportion of the APIs and finished pharmaceuticals are imported from countries outside their territories.

The agreement has enabled both FDA and Swissmedic to increase inspections in countries that represent higher risks of noncompliance.

Origins of GMPs

The WHO drafted the first text on good manufacturing practices (GMP) back in 1967 through a group of consultants following the request of the Twentieth World Health Assembly (resolution WHA20.34).

It was subsequently accepted and entitled: “Draft requirements for good manufacturing practice in the manufacture and quality control of medicines and pharmaceutical specialties.”

In 1969, in resolution WHA22.50, the World Health Assembly accepted the application of the WHO Certification Scheme on the quality of pharmaceutical products placed in international commerce. The GMP text was accordingly recognized as an integral part of the Scheme.

The scope of the Certification was expanded in 1975 by the WHA28.65 resolution to include information related to safety and efficacy, starting materials for use in dosage forms, and so on.

The revised draft GMP requirements were presented in 1992. The text directed actions to be taken separately by production and quality control personnel for the implementation of general quality assurance (QA) principles.

Hygiene, validation, self-inspection, personnel, premises, equipment, materials, and documentation are all covered. Production and quality control practices were later incorporated into pharmaceutical GMP.

Significant advances in GMP have occurred in the intervening years, with important national and international documents, including new revisions, appearing.

For all the latest healthcare industry news from Africa and the World, subscribe to our NEWSLETTER, and YouTube Channel, follow us on Twitter and LinkedIn, and like us on Facebook.