PIC/S and Taiwan

Wikipedia article "Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme".

The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) are two international instruments between countries and pharmaceutical inspection authorities. The PIC/S is meant as an instrument to improve co-operation in the field of Good Manufacturing Practices between regulatory authorities and the pharmaceutical industry.

The PIC (Pharmaceutical Inspection Convention) was founded in October 1970 by the European Free Trade Association (EFTA), under the title of "The Convention for the Mutual Recognition of Inspections in Respect of the Manufacture of Pharmaceutical Products". The initial members comprised the 10 member countries of EFTA at that time. In the early 1990s it was realized that because of an incompatibility between the Convention and European law, it was not possible for new countries to be admitted as members of PIC. European law did not permit individual EU countries that were members of PIC to sign agreements with other countries seeking to join PIC.

As a consequence the Pharmaceutical Inspection Co-operation Scheme was formed on 2 November 1995. The Pharmaceutical Inspection Co-operation Scheme is an informal agreement between health authorities instead of a formal treaty between countries.

PIC and the PIC Scheme, which operate together in parallel, are jointly referred to as PIC/S. PIC/S became operational in November 1995.

See also

• GxP
• Good Automated Manufacturing Practice (GAMP)
• Corrective and Preventative Action (CAPA)
• Validation (drug manufacture)
• European Medicines Agency (EMEA)
• Food and Drug Administration (FDA)
• Ministry of Health, Labour and Welfare (Japan)
• European Federation of Pharmaceutical Industries and Associations (EFPIA)
• Pharmaceutical Research and Manufacturers of America (PhRMA)
• Secure Access for Everyone

External links

• Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme
• European Federation of Pharmaceutical Industries and Associations (EFPIA)
• Japan Pharmaceutical Manufacturers Association (JPMA)
• Pharmaceutical Research and Manufacturers of America (PhRMA)

【經濟日報╱記者謝柏宏／台北報導】 2008.01.30 05:16 am

為促進本土製藥業與國際市場接軌，衛生署強制要求國內多家藥廠今明兩年投入大規模建廠投資計畫，以符合歐盟「國際標準查廠規範（PIC／S）」的生產標準，總投資金額估計將達100億元，為近年來最大規模的藥廠改造工程。 製藥界指出，依照PIC／S規範，「高致敏性」藥品容易造成交叉汙染，必須設立獨立廠房，「高致敏性」藥品包括：荷爾蒙、抗生素、頭孢子菌素及抗癌用藥。 據了解，「高致敏性」藥品在國內市場占有率至少四成，連同進口商在內，估計一年銷售額約400億元以上。 衛生署去年下半年與製藥業達成協議，並公布「國際標準查廠規」，要求國內168家藥廠若要生產高致敏性藥品，需在民國98年底前，讓廠房達到PIC／S標準。 友華生技董事長蔡正強日前宣布，將投資8億元在雲林虎尾新建全新藥廠，除符合美國食品藥物管理局（FDA）規格外，也以PIC／S為最新的生產規格。 永信藥品董事長李芳全也指出，為符合PIC／S規範，永信已投資4億元興建新針劑廠，預計今年中完工；現有的其他生產線也將投資近1億元，進行設備改造以符合規範。 其餘的中化、生達、杏輝及台灣東洋等上市櫃公司，也自去年下半年至今年起，各自投資1億元至5億元興建新廠，或進行生產線改造。製藥業者預估，有計劃進行生產線改造的藥廠，至少有20家。 台灣區製藥公會理事長黃柏熊表示，衛生署要求各藥廠進行設備改造，各藥廠若無法在明年底前完成，後續可能面臨衛生署不再核發藥證，業界應高度關注。 製藥業者分析，各公司進行生產改造的目的，除在衛生署規定下，爭取國內市場生存空間，各廠近兩年積極拓展海外市場，符合PIC／S規範，也有助廠商進軍歐洲市場，而包括紐澳、加拿大、東南亞等國家，也都落實相同的規定。