Malaysia Drug Regulators See Harmonization As Long-term Plus For Domestic Industry

Malaysia’s National Pharmaceutical Control Board sees harmonization as opening doors for investment and local manufacturers to gain markets regionally and abroad.

KUALA LUMPUR – Harmonization for manufacturing and drug approval standards remains a top goal for Malaysia’s National Pharmaceutical Control Bureau as it underpins federal policies to build a more diverse biomedical industry chain and give local companies more regional export options.

Since a push for regulatory harmonization began in 1999, Malaysia has joined the Pharmaceutical Inspection Convention and the Pharmaceutical Inspection Co-Operation Scheme (known jointly as PIC/S) and adopted European Medicine Agency guidelines on biosimilars among other steps, according to Dato’ Eisah Rahman, senior director of pharmaceutical services for the control board known by its local language acronym BPFK.

(For a legislative overview, see: Malaysia drug laws framework presentation.pdf)

The efforts have been particularly important to plans for a trade pact between the Association of Southeast Asian Nations (ASEAN) to start in 2015 that could ease barriers to regional imports and exports. Malaysia and countries such as Vietnam have already agreed to common data formats and other standards, Rahman said at the National Regulator Conference May 9 (Also see "ASEAN Agreement On Pharma Manufacturing Standards Clears Hurdle For Closer Integration" - Scrip, 10 Apr, 2013.).

“The legislative framework and the regulatory efforts are leading to ways to pursue harmonization,” Rahman told PharmAsia News. “Safety remains the prime concern for the BPFK. But there are many other issues too, such as ensuring accessibility and affordability and how we look at best practices internationally from APIs (active pharmaceutical ingredients) to biosimilars.”

Rahman noted that BPFK approved Novartis AG biosimilar Binocrit (epotein alfa), made by Swiss-based Novartis’ generic arm Sandoz International GMBH, based on EMA data.

(See: Regulatory Pharmacy Director Tan Ann Lin’s Malaysia regulatory update presentation.pdf)

The moves to embrace PIC/S and work with international and regional regulators on data files and processes has also paid off closer to home, according to Jimmy T.O. Piong, managing director of Malaysia-based Kotra Pharma, which manufactures and distributes prescriptions under marketing arms Axcel and Vaxcel with a separate production facility to make small volume injectables.

“We now sell to Vietnam because of efforts under ASEAN to bring down both trade and regulatory barriers,” Piong said. “We are looking more and more at Indonesia but there are still many hurdles to entry. However, we will wait for process to gather momentum and think in a few years’ time there will be opening for companies like ours to export with the national health care acts coming in place (Also see "Full Steam Ahead On Expansion For Companies Eyeing Universal Health Care In Indonesia" - Scrip, 25 Mar, 2013.).

Costs Always A Factor As Healthcare Spending Rises

Multinational and domestic drug firms have talked for years about affordable access to medicines in emerging markets like Asia. But pricing and reimbursement policies change rapidly and are not always clear in many of these countries, and local requirements might limit distribution and manufacturing flexibility (Also see "Asia Public Health Care Expansion Hinges On Cost Control Solutions" - Scrip, 2 Apr, 2013.).

Malaysia, an upper-middle income country with a high level of formal sector employment, has yet to establish a social health insurance scheme. Still, primary care services focused on maternal and child health are subsidized and cover almost all citizens and what could be deemed essential drugs are available nearly free or heavily subsidized (Also see "A Closer Look At Southeast Asia With Julien de Salaberry: An Interview With PharmAsia News (Part 2 of 2)" - Scrip, 8 Jan, 2013.).

While not an essential list per se, Malaysia Ministry of Health lists 1,500 drugs under its national medicines policy through its blue book, Rahman said.

(For slides by Salmah Bahri, director of pharmacy practice and development, pharmaceutical services division, Ministry of Health Malaysia, see: Malaysia national medicines policy presentation.pdf)

“The budget is around 2 billion ringgit ($699 million) for a population of around 29 million,” Rahman said. “There is always pressure on cost and access.”

The country imports most of the medicines used at private hospitals, Rahman said, while public hospitals rely on generics, with preference given to domestically manufactured medicines. One issue, however, is that many patients tend to sidestep clinics at the local level in favor of larger public hospitals, driving up costs (Also see "Asia Public Health Care Expansion Hinges On Cost Control Solutions" - Scrip, 2 Apr, 2013.).

Domestic Vaccines Push

Another cost center for the government is its move to detach from dependence on imported vaccines from multinational drug manufacturers, as countries like India, Thailand and Vietnam develop local production.

“Developing a vaccines industry is a security as well as a cost issue,” said Jay Padasian, senior vice president, biomedical, for Biotech Corp, or Malaysian Biotechnology Corp.

Padasian is leading a push to develop public-private partnerships for vaccine production in Malaysia, targeting the potential demand for pneumococcal, meningococcal and seasonal influenza through on-license fill-and-finish deals that could be pre-qualified and sold to U.N. agencies in order to keep production steady.

In addition, Padasian said Malaysia is an obvious choice to develop vaccines for tropical diseases like dengue and malaria, something several large multinational companies including Takeda Pharmaceutical Co. Ltd. are ramping up research and acquisitions to address (Also see "Takeda’s Inviragen Acquisition Ramps Up Vaccines Push" - Scrip, 9 May, 2013.).

Indeed, neglected diseases are gaining a higher profile in multinational drug development programs (Also see "A Snapshot Of Neglected Disease Drug Development: Dengue Fever" - Scrip, 24 Apr, 2013.).

“Malaysia may be too small to support a large vaccine production base just for domestic demand, but there are ways to cooperate regionally on production and we’re looking at them,” Padasian said.

(For presentation slides on Malaysia’s vaccine efforts, see: Malaysia vaccines presentation.pdf )

Harmonization And Halal

The push to build vaccine capacity in Malaysia highlights the need for products that conform to harmonized standards for halal-certified pharmaceuticals in a Muslim-majority country.

Much of the process for bringing along promising research or ensuring halal pharmaceuticals – drugs that conform with Muslim law on prohibitions on food and drink as well as slaughtering rituals for animal products used in drug manufacture – depend on following the same sourcing and manufacturing guidelines already adopted by the regulator, according to Tajuddin Akash, a pharmacist with BPFK.

Neighboring Indonesia, the world’s fourth-most populous country with more than 240 million people and majority Muslim, has also looked at how to build a halal pharmaceutical and food regulatory system, and is now considering legislation. But the Indonesian Food and Beverage Association and the International Pharmaceutical Manufacturers Group believe any certification, if needed, should be voluntary (Also see "Indonesia Halal Certification Bill Seen As Threat To Domestic Vaccines Manufacturers Gains Traction In Parliament" - Scrip, 19 Nov, 2012.).

Malaysia has general guidelines for manufacturing and handling of halal pharmaceuticals that need to comply with good manufacturing processes as outlined under PIC/S, Akash said. (For details, see: Malaysia Halal drugs presentation.pdf)

“Along with other requirements for halal manufacture, supply documentation and handling, a halal certificate needs to be issued by the competent authority, the Department of Islamic Development in Malaysia, which is recognized by 71 bodies in 29 countries,” Akash said.