KUALA LUMPUR, Oct 28 — A trade agreement between Malaysia and the United States expedites the entry of American-made pharmaceuticals and medical devices into the Malaysian market by cutting regulatory red tape.
The Malaysia-US Agreement on Reciprocal Trade (ART) – which was signed by Malaysia Prime Minister Anwar Ibrahim and US president Donald Trump last Sunday during a bilateral meeting on the sidelines of the 47th Asean Summit here – breaks down non-tariff barriers for US industrial exports.
This includes Malaysia “accepting US Food and Drug Administration (FDA) certificates and prior marketing authorisations for medical devices and pharmaceuticals,” according to a fact sheet by the Office of the United States Trade Representative (USTR).
Section 2 of Annex III of the legally binding Malaysia-US trade agreement, published by the White House last Sunday, addresses non-tariff barriers in Malaysia, including medical devices and pharmaceuticals under Article 2.4.
“Malaysia shall accept a prior marketing authorisation issued by the FDA as sufficient evidence that a pharmaceutical product manufactured in the United States meets Malaysia’s requirements for marketing authorisation in its country,” states ART.
“Malaysia shall not require periodic re-authorisation for a pharmaceutical product manufactured in the United States that has previously received marketing authorisation from the United States, unless Malaysia identifies a significant safety, effectiveness, or quality concern.”
On medical devices, ART requires Malaysia to accept a prior approval or clearance issued by the US FDA as “sufficient evidence that a medical device manufactured in the United States meets Malaysia’s requirements for marketing authorisation”. Malaysia also shall not require market authorisation for low-risk medical devices where marketing authorisation is not required by the FDA.
“For greater certainty, this paragraph does not preclude Malaysia from maintaining registration requirements. Malaysia shall ensure that any registration requirement does not impose any additional conformity assessment procedures or other evaluation of marketing authorisation.”
ART requires Malaysia to recognise audits and certificates of device manufacturers’ quality management systems that are in accordance with the requirements established by the Medical Device Single Audit Program (MDSAP) and conducted by auditing organisations authorised by the regulatory authorities participating in MDSAP to audit under the MDSAP requirements, “and shall not impose additional regulatory requirements beyond those required for MDSAP”.
“Malaysia shall adopt relevant scientific or technical guidance documents developed through the International Medical Device Regulators Forum (IMDRF), when developing or implementing regulations for marketing authorization of medical devices.”
The trade deal also requires Malaysia to accept the FDA’s electronic certificates of pharmaceutical product (eCPP) and electronic certificates to foreign government (eCFG) as “sufficient for Malaysia’s approval requirements for pharmaceuticals and medical devices. Malaysia shall not require hardcopies, original copies, authenticated copies, wet signatures, or apostilles of FDA certificates.”
“Malaysia shall accept the results of a good manufacturing practice surveillance inspection conducted by the FDA of a manufacturing facility for pharmaceutical products without further need for an inspection or reinspection performed by Malaysia’s relevant regulatory authorities when the following conditions apply:
- the manufacturing facility is within the territory of the United States; and
- the most recent FDA inspection report, as provided by the facility, is classified as no action indicated, demonstrating no objectionable conditions or practices.”
Article 2.5 of Annex III of ART states that Malaysia does not require industrial goods, including cosmetics, pharmaceuticals, and medical devices, to be certified halal and “shall not impose any such requirement”.
It’s important to note that the trade agreement’s relaxation of non-tariff barriers in Malaysia for imported pharmaceuticals and medical devices from the US favours products made in America, not products by American companies necessarily that may be manufactured outside the US.
For example, during the Covid-19 pandemic, US drugmaker Pfizer’s supply of Covid vaccines for Malaysia was produced in Puurs, Belgium.
Reuters recently reported plans by global drugmakers – including American corporations Pfizer, Eli Lilly, and Johnson & Johnson, as well as UK-based GSK, Anglo-Swedish drugmaker AstraZeneca, and Swiss pharmaceutical companies Roche and Novartis – to expand US manufacturing.
CodeBlue previously reported data from the Pharmaceutical Research and Manufacturers of America (PhRMA) that only 22 per cent of new medicines are available in Malaysia and only 2 per cent of new medicines are available quickly in Malaysia, based on 460 new medicines launched from 2012 to end of 2021.
PhRMA further reported that new medicines are delayed almost three years after global first launch in Malaysia, based on new medicines launched from 2012 to end of 2021.
Article 2.17 under Annex III of ART about intellectual property requires Malaysia to fully implement the 1977 Budapest Treaty and the 1970 Patent Cooperation Treaty, among others. Malaysia shall also ratify or accede to and fully implement the 1961 UPOV Convention and the 2000 Patent Law Treaty, among others.
Galen Centre: Trade Deal Potentially Increases Availability Of Medicines In Malaysia
Galen Centre for Health and Social Policy chief executive Azrul Mohd Khalib said ART can potentially create access and increase the availability of medicines that are currently not available or launched in Malaysia.
“It could increase the diversity of drugs available and used to treat a particular disease both in the public and private sectors,” Azrul told CodeBlue when contacted for comment on the Malaysia-US trade agreement.
He explained that ART could mean that certificates of pharmaceutical product (CPP) issued by the FDA for both medicines and medical devices manufactured in the US, and prior marketing authorisations issued from that country, would be sufficient evidence for Malaysian regulatory bodies to enable the registration and launch of these products in Malaysia.
“It could mean a much improved and expedited process benefiting pharmaceutical products made in the US and exported to Malaysia,” said Azrul.
He added that Malaysia is known for having one of the most rigorous pharmaceutical regulatory bodies in the region to ensure the safety, efficacy, and quality of medicines.
All drugs must be registered through the National Pharmaceutical Regulatory Agency (NPRA) under the Drug Control Authority. The Medical Device Authority (MDA) regulates medical devices.
“I don’t foresee any changes to the registration pathway, which must be undertaken by the Product Registration Holder (PRH) acting on behalf of the product owner,” said Azrul.
“However, this recent development could mean that US pharmaceutical products and medical devices could benefit from an express lane or highway, leaning on US FDA-issued certificates and post-market authorisations. It could translate to an expedited process for US medicines and medical devices to be made available in the Malaysian market.”
The Galen Centre said ART may not necessarily address issues like the cost of drugs that can be prohibitive, such as those used to treat rare diseases.
However, Azrul also noted that innovator medicines are not necessarily more expensive than generics and biosimilars.
“When there is competition, there is room for negotiation during the procurement process with major entities, such as the government and private hospitals. It is not impossible or unlikely for innovator drugs to be at the same price point or even lower than generics and biosimilars.”
When asked about the impact of ART on the Malaysian pharmaceutical industry, Azrul said it was too early to know at this point.
“Theoretically, if more pharmaceutical products from the US are going to be making their way to the Malaysian market via this express lane, they will be directly competing with existing products made by local pharmaceutical manufacturers.
“Depending on the retail prices, these US products may or may not have an advantage over their local competitors. It could spell trouble for the local industry as their market share may be diluted by US products which are similar to local medicines.”
Azrul also noted that Malaysia’s pharmaceutical market is not large compared to neighbouring countries like Indonesia.
