PICS: WHAT IT HAS MEANT TO MALAYSIA

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PIC/S WHAT IT HAS MEANT TO MALAYSIA

• ABIDA HAQ
• NATIONAL PHARMACEUTICAL CONTROL BUREAU
• MINISTRY OF HEALTH MALAYSIA

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BACKGROUND

• Malaysia became the 26th member of the
  Pharmaceutical Inspection Cooperation Scheme
  (PIC/S) in January 2002.
  
• The only other country in the Asian region which
  is also a PIC/S member is Singapore
  
• Thailand was inspected in January 2008 by four
  PIC/s auditors as part of their application for
  membership
  
• Indonesia and Philippines have expressed their
  interest in joining PIC/S
  
• Taiwan had previously applied but due to some
  technicalities, have not proceeded with their
  application
  
• Currently there are 33 participating authorities
  in PIC/S

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PIC/S' MISSION

• "to lead the international development,
  implementation and maintenance of harmonised Good
  Manufacturing Practice (GMP) standards and
  quality systems of inspectorates in the field of
  medicinal products."

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CURRENT SCENARIO

• Malaysia is a a developing nation
• Realises the need for a certain degree of self-
  dependency and self- sufficiency in the supply of
  medicines
  
• Lead to the growth of the domestic pharmaceutical
  industry

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GOVERNMENT SUPPORT

• In recognition of the strategic importance of the
  pharmaceutical industry, a blueprint for the
  industry has been prepared by the Malaysia
  Industry-Government Group of High Technology
  (MIGHT).

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STANDARDS

• GMP
• To ensure that medicines produced domestically
  comply with the same standards in terms of
  quality, efficacy and safety as imported
  products
• GMP standards used evolved from Malaysian
  standards based on WHO to the European standards

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IMPACT ON THE INDUSTRY

• As compliance with high GMP standards comes at a
  very costly price, it has not been viable for
  Malaysian manufacturers to rely only on the
  Malaysian market for their products

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TRADE ISSUES

• In general, penetrating foreign markets is not
  easy without international confidence in the
  
• standards adopted by the drug regulatory
  authority,
  
• quality of the medicines produced,
• level of GMP implemented by the manufacturers.
• Malaysias ascension into PIC/S has opened new
  doors for the domestic pharmaceutical industry.

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BENEFITS

• GMP inspectors benefited from increased training
  opportunities by attending
  
• PIC/S Seminars
• Expert Circles
• PIC/S Joint Visits Programme.
• PIC/S guidance documents have served to
  standardise and harmonise the understanding and
  interpretation of GMP

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BENEFITS

• Malaysia is currently studying the PIC/S guides
  in its efforts to qualify blood collection
  facilities and those involved in tissues and cell
  cultures.

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BENEFITS

• Networking and the feeling of camaraderie among
  members is demonstrated through the willingness
  to share knowledge and to undertake training of
  fellow inspectors especially in specialised
  areas.

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MUTUAL RECOGNITION AGREEMENTS

• Membership in PIC/S may also facilitate the
  conclusion of agreements between Members at
  various levels.
  
• At the ASEAN level, the Pharmaceutical Products
  Working Group has agreed to use the PIC/S code of
  GMP or its equivalent as the basis for entering
  into the proposed Mutual Recognition Agreement
  for GMP amongst the ASEAN countries.

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ASEAN MRA for GMP

• Final draft of the MRA was discussed at the 14
  Pharmaceutical Products Working Group Meeting in
  Vientiane, Lao in February 2008
  
• Its implementation will probably follow the
  ASEAN-x principle whereby countries which are
  ready will enter into the MRA first without
  waiting for general acceptance by all 10 ASEAN
  countries

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ASEAN MRA for GMP

• When this MRA becomes a reality, it will
  translate into benefits for the regulators and
  the industry both financially and non-financially
  through mutual acceptance of audit reports,
  reduced duplication of inspections and broader
  market access

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ULTIMATE BENEFIT

• To the patient and the consumer, it means
  medicines which are safe, efficacious and of
  reliable quality which will result in improved
  healthcare

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THANK YOUTERIMA KASIH