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18 Jun 2018

What is PIC/S? Is India part of PIC/S?

What is PIC/S?

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.

Pharmaceutical Inspection Co-operation Scheme (PIC/S) is the international instruments between countries and pharmaceutical inspection authorities, i.e regulatory bodies. 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.

Is India part of PIC/S?

As on date, India is not part of PIC/S.

Which are the countries are presently member of PIC/S?

  • Argentina
  • Austria
  • Australia
  • Belgium
  • Canada
  • Switzerland
  • Cyprus
  • Czech Republic
  • Germany
  • Denmark
  • Estonia
  • Spain
  • Finland
  • France
  • United Kingdom
  • Greenland
  • Greece
  • Hong Kong
  • Croatia
  • Hungary
  • Indonesia
  • Ireland
  • Israel
  • Iceland
  • Italy
  • Japan
  • South Korea
  • Liechtenstein
  • Lithuania
  • Latvia
  • Malta
  • Malaysia
  • Netherlands
  • Norway
  • New Zealand
  • Poland
  • Portugal
  • Romania Sweden
  • Singapore
  • Slovenia
  • Slovakia
  • Thailand

What are the advantage to become part of PIC/S?

  • Major advantage for countries to being part of PIC/S is International GMP harmonisation. By taking part in the meetings of the PIC/S Committee, PIC/S Participating Authorities are involved in the development and harmonisation of international GMP guides and guidelines. The PIC/S Committee also actively promotes the uniform interpretation of GMP and Quality Systems for GMP Inspectorates.
  • Membership in PIC/S may also facilitate the conclusion of other agreements, e.g. Mutual Recognition Agreements, between Members at various levels (e.g. Australia-Canada MRA, EU-Switzerland MRA, etc.). During the recently concluded initial negotiation on ASEAN MRA on GMP Inspection, PIC/S Membership accession was accepted as one of the essential criteria for MRA.
  • There are also indirect benefits to industry when their relevant Regulatory Authority becomes a Member of PIC/S. These benefits may include the following:
    • Reduced duplication of inspections
    • Cost savings
    • Export facilitation
    • Enhanced market access

    Although PIC/S is not a trade agreement, Membership in PIC/S may facilitate the export of pharmaceuticals. Some non-PIC/S Authorities accept GMP Certificates from PIC/S Participating Authorities. This means that non-PIC/S Authorities and organisations have a greater confidence in medicines manufactured in countries where the Regulatory Authority is a PIC/S Participating Authority. Consequently, the pharmaceutical industry located in these countries indirectly benefits from PIC/S Membership.

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