Malaysia API

MALAYSIA

    Malaysia is a country of 27 million with a growing economy. It is also a top healthcare destination in Southeast Asia. Choosing the right business and regulatory strategy for your medical products is the key to being successful in Malaysia. Pacific Bridge Medical has a number of expert partners and strategic affiliates on the ground in Malaysia who can successfully assist American and European medical companies with a number of issues ranging from navigating medical device and/or drug regulations to building a business strategy.
    http://www.mida.gov.my/en_v2/index.php?page=pharmaceuticals
    http://iplj.net/blog/wp-content/uploads/2009/09/Note-DATA-PROTECTION-IN-A-US-MALAYSIA-FREE-TRADE-AGREEMENT-NEW-BARRIERS-TO-MARKET-ACCESS-FOR-GENERIC-DRUG-MANUFACTURERS.pdf

The Malaysian Pharmaceutical Industry

Products
The domestic pharmaceutical industry consists of manufacturers engaged in the process of drug production from research, development and licensing. The potential of the domestic pharmaceutical industry has been recognized by the Malaysian government which has identified it as a strategic industry which should be promoted.

Pharmaceutical products manufactured by the Malaysian pharmaceutical industry can be broadly categorized as:

  1. Prescription
  2. Over-the-counter (OTC)
  3. Traditional medicines
  4. Health and Food supplements

The Prescription medicines comprise patented and generic drugs, the sale and transaction of which are confined to doctors and pharmacists. OTC, traditional medicines and health/food supplements may be sold by non-professional outlets and to members of the public.

The Malaysian pharmaceutical industry has the capability to produce almost all dosage forms, including sterile preparations such as eye preparations, injections (both large and small volume), soft gelatin capsules of various sizes and shapes, time release medications and powders for reconstitution.

The industry can now produce almost 80% of the various categories in the Malaysian Essential Drugs List.

Since 1986 when drug registration was started, the cumulative total number of applications received by the Drug Control Authority (DCA) as at the end of 2005 were, 16,554 for poisons (controlled medicines); 12,529 for non poisons; 28,546 for traditional medicines and 87,532 for cosmetics. As at the end of 2005 the number remaining on the register were 3,711 for prescription products (controlled medicines); 2,831 for OTC products (non poisons); 1,112 for traditional medicines and 82,792 for cosmetics.

Growth Rate
Over the last decade, the Malaysian pharmaceutical market grew at between 8 to 10% annually. The 2004 market size was estimated to be about RM3 billion for prescription and OTC medicines. The market for traditional medicines together with health and food supplements was estimated to be about RM2 billion. However the market still relies, to a significant extent, on imports.

There are currently 296 manufacturers in Malaysia licensed by the Drug Control Authority. Of these, 87 are licensed to produce pharmaceuticals. There are also another 148 manufacturers licensed to produce traditional medicines and 61 for cosmetics.

Exports
Another significant development in the industry is the growth in pharmaceutical exports. The increasing awareness by local manufacturers of the export potential of Malaysian pharmaceuticals had resulted in an average growth of 10.7% between 1995 to 1999 in which the export value totaled RM280 million.

Research & Development
A significant development of the industry over the last decade is the strong emphasis placed by local manufacturers on research and development, particularly in areas of product innovation and improvement as well as in bio-pharmaceutics and natural products with resultant patents.

Regulation
The manufacture and marketing of pharmaceutical products in Malaysia are as heavily regulated as in most developed countries.

All medicines marketed in Malaysia are required to be registered by the Drug Control Authority (DCA) of the Ministry of Health. All manufacturers, importers and wholesalers are required to the licensed by the DCA.http://www.bpfk.gov.my

The registrations of prescription and OTC medicines, requires proof of efficacy, quality and safety, and are subjected to stringent screening and testing as well as regular and random post-marketing surveillance and testing. All manufacturers in Malaysia are subjected to regular and random inspection by DCA inspectors.

To be licensed, manufacturers must be in full compliance with the Code of Good Manufacturing Practice, which is currently based on the PIC Code as Malaysia is currently a PIC/S member.

Medicines are regulated under the Poisons Act, the Dangerous Drugs Act and the Drugs Act. Medicine advertisements require prior approval by the Medicines Advertisement Board.

Malaysia is a member of the WTO and has acceded to the TRIPS agreement. Patents are registered and copyrights are protected.

 




















































Links




Following are world’s 10 top health and pharmaceutical companies with presence in Malaysia. While many of them have major facilities and manufacturing plants in Malaysia, a few have representatives who drive the sales and marketing functions of the companies.

These are notable companies with strong reputation and strong background which are targeted by many top performers in the pharmaceutical industry. And you are probably one of them. The list is not according to any latest year end revenues or other merits but these companies have been consistently been in the world’s top rank for the past decade or so on many fronts.

Yes, they are all multinationals.

1. Merck, Sharp and Dohme (MSD)

Merck Sharp and Dohme (MSD) Pharmaceutical MalaysiaThe official name is Merck & Co. Inc but the company is more popularly known as MSD or Merck, Sharp and Dohme outside of its country of origin, United States. While it was established in the US, the entity belongs to a German giant known as Merck KGaA. The company ranks among the top 7 most profitable companies in the world, and set up its first Malaysia office in 1997.

2. Pfizer

Pfizer MalaysiaIf sales and revenue are taken into account, Pfizer tops the list. The New York based company produced high selling medicines and drugs which include the famous Viagra pills. Pfizer’s Malaysia operation started more than 40 years ago as a branch of a Singapore registered company. Today, the company employs more than 400 staff nationwide, scattered around in its HQ Shah Alam as well as in Penang, Ipoh, Melaka, Kota Bharu, Kuantan, Kota Kinabalu and Kuching.

3. GlaxoSmithKline (GSK)

GSK MalaysiaGSK is a British based company producing healthcare, pharmaceutical and biological products with strong reputation on research and development (R&D) of broad range of pharmaceutical products covering anti infection, respiratory, metabolic, oncology and vaccines. GSK has been operating in the country for more than 50 years and today employs close to 600 people in its main facilities based in Ampang, Kuala Lumpur.

4. Eli Lilly

Eli LillyEli Lilly, which was named after its founder, the late Colonel Eli Lilly has its global headquarter is based in Indiana, United States and has been in existence for more than 130 years. Eli is a Fortune 500 corporation with revenues in excess of USD15 billion and employs 42,000 people worldwide and market its medicines in over 140 countries. The company also has major research and development facilities in nine countries.

5. Johnson & Johnson

Johnson and JohnsonAnother American corporation, Johnson & Johnson is a massive entity comprising some 250 subsidiaries with its products sold in over 70% of the world’s countries. Some of its very popular range of brands include Johnson’s baby products, Netrogena, Clean & Clear and Acuvue contact lenses. J&J Malaysia operation is backed by a family of 5 subsidiaries, all located in Selangor.

6. Procter & Gamble (P&G)

Procter and Gamble MalaysiaAnother Fortune 500 company, Procter & Gamble not only manufactures pharmaceutical products but also a broad range of other FMCG products including food, household and beauty products. In Malaysia, P&G also works closely with the Education Ministry to leverage help to disabled children and earlier this year, the company started an employee volunteer program where the employees commit to spend an average of 2 hours for volunteerinitiative per week.

7. Wyeth

Wyeth MalaysiaSince its inception 60 years ago, Wyeth has grown from a small laboratory into a leading pharmaceutical company and is well-known for its manufacturing of over-the-counter (OTC) prescription drugs for women’s care, neuroscience, vaccines musculo-skeletal disorder, oncology and others. The company boasts its presence with more than 50,000 workforce employed worldwide in more than 140 countries, including Malaysia.

8. Bayer

Bayer MalaysiaBayer AG is a German-based company, and is the world’s third largest pharmaceutical company in terms of revenue. Bayer Malaysia supplies a diverse range of products and services, namely pharmaceuticals, materials, over-the-counter drugs, nutritional supplements, environmental health products, agrochemicals and veterinary products, and employs about 200 people nationwide.

9. Novartis

Novartis MalaysiaNovartis was created not long ago in 1996 out of a merger between 2 Swiss companies, which goes down as one of the largest mergers in the corporate history. The company employs a massive 100,000 workforce, with the pharmaceutical division focused on major areas including cardiovascular and metabolism, oncology & hematology, respiratory and immunology.

10. Abbott Laboratories

Abbot Laboratories MalaysiaAbbott Laboratories, which was established by a practicing medical officer in the 19th century, today operates in more than 130 countries worldwide, employing close to 70,000 staff. Abbott Malaysia is headquartered in Shah Alam, Selangor and specializes in medical nutrition, diabetes care, pediatric nutrition and consumer pharmaceutical and products.

Web-Resources: National OrganizationsInternatinal Links Government HospitalsPrivate Hospitals Doctors PharmacistsNational Specialists Register Drugs Search (MIMS) Registered Drugs Search (MOH)





Click here to link the Pharmaceutical Services Division of the Ministry of Health Malaysia
www.Pharmacy.gov.my
Click here to llink to the National Pharmaceutical Control Bureau (NPCB / BPFK) of the Ministry of Health Malaysia
www.BPFK.gov.my
    Click here to visit the Ministry of Health Malaysia website on Influenza A (H1N1)
 

 


MUST READ PDF


Other Information


Business



Regulatory




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ESSENTIAL GOVT SITE




Malaysian Pharmaceutical Society
http://www.mps.org.my/ 
5B Lorong Rahim Kajai 13, Taman Tun Dr. Ismail, 60000 Kuala Lumpur 
Tel: 03 7729 1409, Fax: 03 7726 3749 
As shown in MyCen Map 

National Pharmaceutical Control Bureau NPCB - Biro Pengawalan Farmaseutikal Kebangsaan BPFK
Drug Control Authority - DCA 
http://www.bpfk.gov.my/
Jalan Universiti, Peti Surat 319, 46730 Petaling Jaya
Tel: 03 7957 3611, Fax: 03 7956 2924 
As shown in MyCen Map 

Pharmaceutical Association of Malaysia 
http://www.phama.org.my/ 
75-3, Jalan Medan Setia 1, Plaza Damansara, 50490 Kuala Lumpur
Tel: 03 2096 2493, Fax: 03 2095 2143 

Pharmaceutical Services Division of the Malaysian Ministry of Health
http://www.pharmacy.gov.my/ 
Lot 36, Jalan Universiti, 46350 Petaling Jaya
Tel: 03 7968 2200, Fax: 03 7968 2222 
As shown in MyCen Map 

Malaysian Organisation of Pharmaceutical Industries - MOPI 
http://www.mopi.org.my/ 
1st Floor, Wisma Yan, 17 & 19, Jalan Selangor, 46050 Petaling Jaya 
Tel: 03 7957 3070, Fax: 03 7956 0018 
As shown in MyCen Map








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