2015 Annual Meeting Education RecapBob Tribe, AP Regulatory Affairs Advisor, provided a brief background and update on two organizations influencing the pharmaceutical industry in the Asia-Pacific region.

PIC/S:

The biggest GMP change in the Asia-Pacific region is the growing influence of the Pharmaceutical Inspection Cooperation Scheme (PIC/S).  PIC/S is made up of the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-operation Scheme.  These are the two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive co-operation in the field of GMP.

The PIC/S is a forum for:

  • Networking and confidence building
  • Exchanging information and experience on GMP
  • Focusing on Quality Systems for Inspectorates
  • Training of GMP inspectors
  • International harmonization of GMP

Of the 24 countries in the Asia-Pacific region, to-date 18 countries are being influenced in some way by PIC/S.

Tribe stated “Data integrity is a current hot topic for many of the PIC/S Inspectorates”.

Association of Southeast Asian Nations (ASEAN):

  • Founded in 1967 and comprises 10 countries of South East Asia
  • Aiming to harmonize regulations prior to the establishment of an ASEAN Economic Community (AEC) by the end of 2015
  • ASEAN is collaborating with PIC/S, ISPE & other parties to assist with training and developing equivalency
  • Benefits:
  • Avoid duplication of GMP inspections within ASEAN
  • Savings of time, resources and cost for regulators and industry
  • Facilitates trade in medicinal products
  • Quicker access to medicines by patients
  • Increased competitiveness of ASEAN countries

Tribe concluded his presentation by touching on the current state of the pharmaceutical industry in India and China.

India:

  • GMP requirements currently issued by Central Drugs Standard Control Organization (CDSCO)
  • Recent issues:
  • Lack of patent protection
  • 40% of OTC & generic prescription medicines consumed in USA come from India
  • US FDA investigators currently blitzing Indian drug plans
  • Data integrity fraud
  • World Health Organization (WHO) estimates 1 in 5 drugs made in India are counterfeit or fake
  • Government is resisting industry request to join PIC/S

China:

  • Getting serious about GMP
  • Nationwide crackdowns on sale of fake and counterfeited medicines
  • New China GMPs – combination of PIC/S and WHO requirements
  • Recent issues:
  • New GMP Annexes
  • Un-announced inspections in China
  • Decentralization of GMP inspections
  • GMP controls over APIs recently strengthened
  • Contamination scares:
  • Heparin
  • Melamine
  • Chromium in hard shell capsules

As pharmaceutical companies explore other regions to manufacture medicines, it is important to be aware of what is going on at a local level in each of these areas to better understand how you can work with them and in what capacity.

For additional insight into the Asia-Pacific region, review the Asia-Pacific GMP Update Part 1.

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