Article-03: PIC/S(Pharmaceutical Inspection Co-operation Scheme)

Background:

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) was established in 1995 as an extension to the Pharmaceutical Inspection Convention (PIC) of 1970.

The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is a non-binding, informal co-operative arrangement between Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products for human or veterinary use. PIC/S presently comprises 56 Participating Authorities all over the world (Europe, Africa, America, Asia and Australasia).

Following countries are the part of PIC/S,

     U.S. Food and Drug Administration (US FDA)-USA

     Medicines & Healthcare Products Regulatory Agency (MHRA)-United Kingdom

     Health Canada / Santé Canada-Canada

     Veterinary Medicines Directorate (VMD)-United Kingdom

     Pharmaceuticals and Medical Devices Agency (PMDA)-Japan

     Ministry of Health, Labour and Welfare (MHLW)-Japan

     Pharmacy and Poisons Board of Hong Kong (PPBHK)- Hong Kong SAR, China

     Taiwan Food and Drug Administration (TFDA)- Chinese Taipei

     Federal Commission for the Protection Against Sanitary Risks (COFEPRIS)-Maxico

     State Service of Ukraine on Medicines and Drugs Control (SMDC)-Ukraine

     Medicines and Medical Devices Safety Authority (Medsafe)-New zealand

     Turkish Medicines and Medical Devices Agency (TMMDA)-Turkiye

     Food and Drug Administration (Thai FDA)-Thiland

     Swiss Agency for Therapeutic Products (Swissmedic)-Switzerland

     Swedish Medical Products Agency (MPA)-Sweden

     Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)-Spain

     South African Health Products Regulatory Authority (SAHPRA)-South Africa

     Javna agencija Republike Slovenije za zdravila in medicinske pripomočke (JAZMP)-Slovenia

     State Institute for Drug Control (SIDC)-Slovak Republic

     Health Sciences Authority (HSA)-Singapore

     Saudi Food and Drug Authority (SFDA)-Saudi Arabia

     National Agency for Medicines and Medical Devices of Romania (NAMMDR)-Romania

     Autoridade Nacional do Medicamento e Produtos de Saúde IP (INFARMED IP)-Portugal

     Chief Pharmaceutical Inspectorate (CPI)-Poland

     Norwegian Medical Products Agency (NOMA)-Norway

     Inspectie Gezondheidszorg en Jeugd (IGJ)-Netherland

     Malta Medicines Authority (MMA)-Malta

     National Pharmaceutical Regulatory Agency (NPRA)-Malaysia

     State Medicines Control Agency (SMCA)-Lithuania

     Office of Healthcare- Liechtenstein

     State Agency of Medicines- Latvia

     Ministry of Food and Drug Safety (MFDS)-Korea

     Directorate General for Animal Health and Veterinary Medicinal Products- Italy (Veterinary Agency)

     Italian Medicines Agency -Italy

     Institute for Standardization and Control of Pharmaceuticals (ISCP)-Israel

     Health Products Regulatory Authority (HPRA)-Ireland

     Iran Food and Drug Administration (IFDA)-Iran

     Indonesian Food and Drug Authority (Badan POM)-Indonesia

     Icelandic Medicines Agency (IMA)-Iceland

     National Center for Public Health and Pharmacy (NCPHP)- Hungary

     Greek National Organisation for Medicines-Greece

     Federal Ministry of Health -Germany

     Agency for Food, Environmental & Occupational Health Safety-France

     Finnish Medicines Agency (FIMEA)-Finland

     State Agency of Medicines (SAM)- Estonia

     Danish Medicines Agency (DKMA)-Denmark

     Institute for State Control of Veterinary Biologicals and Medicines (ISCVBM)- Czech Republic

     Pharmaceutical Services (CyPHS)- Cyprus

     Agency for Medicinal Products and Medical Devices of Croatia-Croatia

     Bulgarian Drug Agency (BDA)

Japan's Ministry of Health, Labor and Welfare (MHLW) and Japan's Pharmaceuticals and Medical Devices Agency (PMDA) count as one PIC/S Participating Authority. The Japanese Prefectures are represented by MHLW.

Roles and Responsibilities:

PIC/S aims at harmonizing inspection procedures worldwide by developing common standards in the field of GMP and by providing training opportunities to Inspectors.

This is to be achieved by developing and promoting harmonized GMP standards and guidance documents; training competent authorities, in particular Inspectors; assessing (and reassessing) inspectorates and facilitating the co-operation and networking for competent authorities and international organisations.

PIC/S’ vision is to enable one inspection per site that is fit for all regulatory authorities.

Becoming a member of PIC/S:

Before an Authority is accepted by PIC/S, a detailed assessment is undertaken to determine whether the Authority is able to apply an inspection system comparable to that of current PIC/S Authorities. This assessment involves an examination of the Authority’s GMP inspection and licensing system (or equivalent), quality system, legislative requirements, inspector training, etc. It is followed by a visit by a PIC/S delegation to observe in particular inspectors carrying out routine GMP inspections. Membership may take several years to achieve, during which time various changes and improvements may be recommended by the PIC/S Committee. PIC/S introduced in 2014 a pre-accession procedure to better prepare potentially interested Authorities for PIC/S accession. The pre-accession procedure offers the advantage of allowing a Competent Authority to identify the gaps between PIC/S requirements and its GMP Regulatory Compliance Programme. In line with the Joint Reassessment Programme, existing PIC/S Participating Authorities are also reassessed for equivalence on a regular basis. This ensures that both new applicants and older members fulfill the same requirements.

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