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Latest News

International Good Manufacturing Practice Traning Program 2018

International Good Manufacturing Practice Traning Program 2018

PDF DOWNLOAD HERE (http://mopi.org.my/files/MOPIGMPTraining2018-BrochureVersion3.pdf)

Collaborative Regulatory Training Seminar 2016

Collaborative Regulatory Training Seminar 2016

Collaborative Regulatory Training Seminar 2016: Challenges Issues with Registration Variation Applications (9 –...

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about

Background

The Malaysian Organisation of Pharmaceutical Industries (MOPI) was incorporated on March 6th 1981, as a company limited by guarantee, by eight local, foreign and joint venture companies involved in the manufacture of pharmaceutical products.

MOPI membership is open to all manufacturers of pharmaceutical products whose manufacturing facilities in Malaysia are licensed by the Drug Control Authority, Ministry of Health. All Associate Membership category is also available on application.

MOPI's original membership of eight has grown to the current 42. All major pharmaceutical manufacturers in the country are members of MOPI.

Main Activities
  • MOPI, in co-operation with the government and other relevant bodies, represents the interests of the pharmaceutical industry.
  • Promotion and development of the pharmaceutical industry.
  • Foster closer co-operation among members of the Industry.
  • Facilitate and encourage the development, exchange and transfer of information and technology, domestically and internationally.
  • Promote and facilitate orderly trade in life science products.

Strategic Role

The MOPI members collectively produces about 35% of Malaysia’s medicine requirements. In terms of product range, MOPI members collectively have the capability to manufacture more than 80% of the products in the National Essential Drugs List of Malaysia.

To a large extent, MOPI’s existence has been a medium and catalyst for the rapid development and capitalization of the local pharmaceutical industry during the last decade.

It has evolved into a modern and sophisticated sector of the Malaysian economy, one that is capable of producing a wide range of products in compliance with the PIC/S standards of Good Manufacturing Practice. MOPI has also taken on the role of training personnel in the industry in the latest GMPand technologies evolving in the industry.
Having invested in high-technology machinery and equipment and formalized training, MOPI members now have the capability to manufacture a wide range of products including large and small volume injectables, novel drug delivery systems, high technology testing and analytical equipment to meet internationally accepted standards of quality assurance.

Research and development is another key area for MOPI members. The focus areas are product development, formulation improvement, dosage fabrication and novel drug delivery systems which are carried out either in-house or in collaboration with tertiary institutions in the country.

Affiliations & Representations

ASEAN Pharmaceuticals Club
MOPI represents the Malaysian pharmaceutical industry in the ASEAN Pharmaceutical Industry Club, an organization which it had helped to form under the ASEAN Chambers of Commerce and Industry.

Pharmaceutical Inspection Convention (PIC)
Malaysia is a member of Pharmaceutical Inspection Cooperation Scheme, PIC/S Service.

International Generic & Biosimilar Medicine Association (IGPA)
Malaysia is a member of the International Generic & Biosimilar Medicine Association.

Dialogues with Ministry of Health and National Pharmaceutical Control Bureau
MOPI also holds regular dialogues with the Health Ministry and the National Pharmaceutical Control Bureau to resolves issues affecting the industry.

Dialogues with Ministry of International Trade & Industry Since 1984, MOPI has acted as representative for the Malaysian pharmaceutical industry in the annual dialogues with the Ministry of International Trade and Industry.

Dialogues with Ministry of Domestic Trade & Consumer Affairs MOPI participates in the annual dialogue representing the industry on matters pertaining to intellectual property and consumer protection.



The Malaysian Pharmaceutical Industry

The Malaysian government has identified the domestic pharmaceutical industry as an industry to be developed and promoted under it’s new economic development plan.

Pharmaceutical products manufactured can broadly be classified as:

  • Prescription Medicine
  • OTC (over the counter) Medicine
  • Herbal and Health Supplements
  • Traditional Medicine

These are produced in almost all possible pharmaceutical dosage forms.

In 1986, drug registration was introduced in Malaysia and the Drug Control Authority (DCA) established. All drugs/medicine in pharmaceutical dosage forms and cosmetics have to be registered before sale and marketing is permitted in the country.

Growth

In 2009, the total market size for Prescription and OTC
medicine was estimated at RM4.5 billion while the traditional
medicine and health supplements market was estimated at
RM3 billion. Market growth has been fairly consistent at
between 8% - 10% annually for the past several years.

Of the 250 DCA licensed manufacturers in 2011, 74 are
licensed to manufacture prescription and OTC medicines
while the remaining 176 are licensed traditional medicine
manufacturers.

There are a further 207 licensed cosmetic/toiletries
manufacturers.

Exports

Malaysian manufacturers currently export to countries in South East Asia, Africa, and the Middle East with new markets being explored beyond these countries. Growth in exports has been steady at between 10% to 12% annually.

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Research & Development

Strong emphasis is placed on R & D, both in-house and in collaboration with Universities, by domestic manufacturers. In some instances, collaborative work is also being undertaken with innovator companies. R & D outcomes in bio-pharmaceutics and traditional medicines have resulted in several patent filings.

Regulation

The manufacture and marketing of pharmaceutical products in Malaysia is strongly regulated as is in most developed countries.

Malaysia was admitted a member of PIC/S in 2002 and manufacturers are required to be in compliance with the CGMP of PIC/S. Please refer to the regulatory agency: http://www.bpfk.gov.my for more details.

Malaysia is also a member of the WTO and has acceded to the TRIPS agreement. Patents are registered and
Trademarks/Copyrights protected.

 

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The Malaysian Organisation of Pharmaceutical Industries (MOPI) was incorporated on March 6th 1981, as a company limited by guarantee, by eight local, foreign and joint venture companies involved in the manufacture of pharmaceutical products......Readmore

 

 

 

Contacts

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Tel:  +603-7931 9003
Fax: +603-7932 2730
Address:  GLOBAL BUSINESS & CONVENTION CENTRE, MEZZANINE FLOOR, BLOCK A, NO. 8, JALAN 19/1, SECTION 19, 46300 PETALING JAYA, SELANGOR DARUL EHSAN, MALAYSIA