The Legislative Yuan Passed the Third Reading for Partial Amendment of Provisions in the Pharmaceutical Affairs Act, Strengthening Our National Drug Management System and Gearing It to the International Standards


To enhance the quality of pharmaceutical development and drug safety in Taiwan, Food and Drug Administration (FDA) amended the related provisions in the Pharmaceutical Affairs Act (PAA) for the purpose of perfecting the management system of drug manufacturing facilities and strengthening the control over the quality of imported drugs. The drafted amendment passed the third reading in the Legislative Yuan on June 5, 2012. The amended provisions will not only contribute to the promotion of the development of biotechnology industry in the future, but also reassure the drug quality and safety of all compatriots.

The current amendments of the PAA are summarized below:

(1)At present, due to the lack of legal grounds against drug manufacturers seriously violating the Good Manufacturing Practice (GMP) standards, our legal system is unable to ban such manufacturers from continuing to manufacture drugs that pose safety and quality concerns. Under the current amendments, the management of “manufacturing” and “products” is separated, and the amendments clearly state that drug manufacturers must pass the competent authority’s inspection for compliance with the GMP standards and obtain the “pharmaceutical manufacturing license” before the manufacturing process can be initiated. If there is a major violation of GMP, appropriate measures can be taken to terminate or invalidate the item under the original manufacturing license without abolishing the “drug permit license”. Such measures can prevent the violating manufacturer from continuing to manufacture or sell drugs with safety concerns, thus achieving the purpose of effective supervision of drug manufacturers for their continued GMP compliance. In addition, only logistics providers performing drug packaging and some emerging biotech industries are not required to apply for a factory registration after the current amendments take effect. The fact that these companies are allowed to manufacture drugs immediately after passing the inspection for GMP compliance will greatly boost the development of related industries.

(2)The current amendments also empower the central health authorities to deny entry of any disqualified drugs by undertaking sampling inspection at the border customs to ensure the quality and safety of imported drugs.

(3) In addition, to expand and effectively utilize the inspection resources, the revised PAA empowers the central health authorities to delegate the sampling inspection and laboratory testing businesses to their subordinate agencies or commission relevant institutions for the businesses, while the quality and credibility of test can be ensured by accreditation of the professional laboratories.

In recent years, FDA has been committed to the promotion of international mutual accreditation of GMP, and actively applying for membership of the “Pharmaceutical Inspection Co-operation Scheme (PIC/S). The system for pharmaceutical manufacturing license is a key criterion for the qualification for PIC/S application. The passing of the third reading for the amendment of provisions of the PAA happened to coincide with the visit of PIC/S delegation (June 4 – 8) to Taiwan for an on-site evaluation of our application. This will greatly and positively help our application for PIC/S membership. After becoming a PIC/S member and signing the Mutual Recognition Arrangement (MRA) with other member countries, Taiwan’s drug exports will not need to undergo repeated factory inspections. This would facilitate the expansion of overseas markets, enhance the international competitiveness of the industry and stimulate the development of the bio-medicine industry in Taiwan.