MFDS moves to speed finished drug approvals

New process applies to applications filed from Oct. 1...MFDS to send API-related requests directly to manufacturers instead of through finished-drug companies

Pilot targets domestic DMF holders...Overseas API manufacturers and same-entity cases excluded

The Ministry of Food and Drug Safety (MFDS) is changing how it communicates requests for supplementary information on active pharmaceutical ingredients (APIs) during the approval process for finished pharmaceutical products, sending them directly to API manufacturers rather than through finished-drug companies.

The change is expected to reduce review delays and improve technical communication by eliminating the multi-step process in which reviews have traditionally been delayed at the finished-drug company stage.

The MFDS Drug Approval Policy Division said on the 30th that it will launch a pilot program, starting with applications for new or amended approvals filed from Oct. 1, under which API manufacturers will be directly notified of requests for supplementary information arising from linked reviews of APIs and finished products.

‘Too much time lost going through finished-drug companies’...addresses industry communication difficulties

The linked ‘API-finished product review’ is a system under which the quality and safety of the active ingredient registered under the Drug Master File (DMF) system are reviewed in conjunction with the marketing authorization application for the finished pharmaceutical product.

Problems first arose when technical questions or requests for additional information concerning the API emerge during the review. Because the finished-drug company is the formal applicant, the MFDS has traditionally sent API-related requests only to that company, which then has to forward them to the API manufacturer and relay its response back to the agency.

The industry has repeatedly raised concerns that this multi-step process can distort highly technical questions involving areas such as synthesis processes and impurity control. Companies have also reported difficulty meeting submission deadlines when API manufacturers are reluctant to share sensitive trade secrets with finished-drug companies.

New drugs and data-submission drugs first...pilot limited to domestic API manufacturers

The key change is that the MFDS will notify API manufacturers directly by official letter, allowing the companies that actually generate the data and possess the relevant technical expertise to immediately identify and respond to requests for supplementary information.

The pilot will cover new drugs, data-submission drugs, and follow-on drugs (generics), as well as applications for changes to their approvals handled by the Pharmaceutical Approval Management Division. It will apply when a finished-drug applicant submits a data-sharing consent form from a DMF holder (Korean API company, including the original registrant and APIs registered through a letter of authorization).

The MFDS will send the relevant API manufacturer an official letter specifying the API name and DMF registration number, along with requests for “supplementary information related to Section 3.2.S, Drug Substance,” of the Common Technical Document (CTD).

The pilot will not apply to products for which a data-sharing consent form has been submitted by an overseas API manufacturer, or where the DMF holder and finished-drug company are the same legal entity. Products under the jurisdiction of regional food and drug safety offices are also outside the scope of the current pilot.

An MFDS official said, “By sending requests for supplementary API information directly to the API manufacturers responsible for preparing the data, we expect to improve review efficiency and support faster approval. We will closely assess the results of the pilot program before deciding how long to continue it and whether to expand its scope.”