Asia-Pacific GMP Update Part 2
Bob Tribe, AP Regulatory Affairs Advisor, provided a brief background and update on two organizations influencing the pharmaceutical industry in the Asia-Pacific region.
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
- 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.
- 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
- 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:
- 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.