On August 27, 2013, the Ministry of Food and Drug Safety (“MFDS”) issued a previous announcement of legislation to amend the Pharmaceutical Affairs Act (the “Act”). The MFDS will collect public opinion until October 28, 2013.
The main revisions to be made are as follows: expanding the scope of consignment manufacture and sales business that is subject to report (Proposed Revision to Article 31 of the Act); introducing reevaluation of quasi-drugs (Proposed Revision to Article 33 of the Act); and improving designation and administration of clinical trial, bioequivalence trial or non-clinical trial institutes (Proposed Revisions to Articles 34-2, 34-3, and 94 of the Act).
Expanding the scope of consignment manufacture and sales business subject to report
Under the current Article 31 of the Act, if a person, who is not a drug manufacturer, intends to consign the manufacture of drugs to others and sell the drugs so manufactured, he has to report consignment manufacture and sales business and obtain product approval relating only to those drugs for which clinical trial is performed after the MFDS has approved the clinical trial plan. Under the proposed revision to Article 31 of the Act, however, the manufacture of biologics (biological products, recombinant DNA products, cell culture products, cell therapy products, gene therapy products, and similar drugs) may also be consigned if the consignment manufacture and sales business is reported and the product approval for the biologics is obtained. Under the amendment, not only drugs, the clinical trial of which has been performed domestically after obtaining the approval of the clinical trial plan from the MFDS, but also biologics, the clinical trial of which has been performed overseas without the approval of the clinical trial plan by the MFDS, are included in the drugs for which product approval can be obtained after reporting consignment manufacture and sales business. The amendment is expected to expedite market access of biologics.
Introducing reevaluation of quasi-drugs
Under the current Article 33 of the Act, only drugs are subject to reevaluation. Under the proposed revision to Article 33 of the Act, however, quasi-drugs are also subject to reevaluation. The revision further provides that the methods and procedures of reevaluation of quasi-drugs will be prescribed by the MFDS in the same way as drugs. The proposed amendment reflects the reality that reevaluation of quasi-drugs are required frequently, even after the product approval/report of the quasi-drugs, for the new safety issues that arise due to the advancement of science and technology.
Reevaluation of drugs are currently administered according to the Act and related regulations including “Regulations on Reevaluation of Drugs”. It is expected that reevaluation of quasi-drugs would be administered in a similar way to reevaluation of drugs. It is likely that regulations on reevaluation of quasi-drugs may prescribe as follows: when the MFDS will announce quasi-drugs that are subject to reevaluation, a person who has reported, or obtained product approval for, the quasi-drugs will submit safety or effectiveness data; the MFDS will evaluate and deliberate on the quasi-drugs, announce the reevaluation results and then take administrative action if necessary. Therefore, when reevaluation of quasi-drugs is introduced, manufacturers of quasi-drugs should consider whether the quasi-drugs may be subject to reevaluation and collect safety and effectiveness data (including data of adverse events) even after the product approval/report in order to avoid potential administrative disposition such as revocation of product approval/report.
Improving designation or administration of clinical trial, bioequivalence trial or non-clinical trial institutes
While the current Article 94 of the Act prescribes punishment for a violation of the regulations regarding the approval of clinical trial plan, it does not contain any provision for punishment for a violation of the regulations regarding the designation of clinical trial institutes. The proposed revision to Article 94 of the Act provides that a person who performed clinical trial at a non-designated institute or asked a non-designated institute to perform clinical trial shall face a fine of up to KRW 10 million or imprisonment for up to three years. Such penalty provisions will contribute to the protection of subjects of clinical trials.