Malaysia seeks to register prescription CBD drugs

KUALA LUMPUR, July 14 – Khairy Jamaluddin announced today that the Ministry of Health (MOH) will unveil a framework later this year for the registration of prescription drugs containing cannabidiol (CBD).

This marks the first step in what is likely to be a lengthy process to define a commercial and legal pathway to bring products containing the cannabis compound to market in Malaysia.

Once the framework is published, the National Drug Regulatory Agency (NPRA) will accept proposals from pharmaceutical companies on the types of products they wish to register, against which the NPRA will assess the safety and efficacy of the products, said the Minister of Health.

“Each pharmaceutical product must have a Product Registration Holder (PRH) in Malaysia. Typically, this is a pharmaceutical company active in the field of pharmacy. We will publish the framework for product registration CBD later this year.

“After that, the NPRA will evaluate the proposals, and my goal is that by next year we can start registering some CBD products,” Khairy told reporters after the launch of the study report on Center Drug Collection.

“We have to look at the validity of the product. We need to look at the data in terms of the safety and efficacy of the product for certain diseases, but also in terms of the education and scientific exposure that needs to be given to physicians in Malaysia.

“Because right now I’m only looking at prescription CBD, not self-medicating, and certainly not for recreational use, far from it. So I think for us to consider using these products, we need to take prudent action by reviewing international practices and scientific data,” he added.

In his speech at the launch of the Drug Perceptions Study Report by The Centre, a local think tank co-founded by Khairy, Khairy said he was “convinced” of the evidence for CBD.

“I’m convinced of the science because I’m working internally to make sure everyone in the Department of Health is behind this. As with any psychoactive substance, great care must be taken in how one proceeds. But I am convinced of the evidence for CBD,” he said.

Khairy said researchers from Universiti Malaya will conduct clinical trials on the use of CBD for specific medical conditions in Malaysia.

“It will be added as a use case for CBD,” Khairy said. “When we have evidence, from a clinical trial perspective, [on the efficacy of CBD] for certain conditions, this opens the use of CBD to physicians to prescribe.

Khairy officially recognized the use of cannabis for medical purposes in November last year, stating that existing legislations that regulate cannabis and its by-products in Malaysia, including the Dangerous Drugs Act 1952, the Poisons Act 1952 and the Sale of Drugs Act 1952, do not prohibit the use of cannabis for medical purposes.

A product containing cannabis used for human medical purposes may be imported and consumed in Malaysia if that product complies with the requirements of the law.

code blue also reported that the NPRA confirmed the approval of a cannabis-derived prescription drug to treat muscle spasms and spasticity in multiple sclerosis.

Despite being approved in 2014, Sativex – an oromucosal spray of a cannabis extract formulated with CBD and THC, the psychoactive chemical component of cannabis – was pulled from the Malaysian market three years later because it was not commercially viable. . Sativex was developed by GW Pharmaceuticals, a manufacturer of therapeutic cannabinoids based in Ireland.

This means that Malaysia currently has no registered CBD-infused treatments.

CBD is one of more than 80 chemical compounds, or cannabinoids, found in the Cannabis-sativa plant. Besides CBD, the other most well-known compound is delta-9-tetrahydrocannabinol (THC), well known for producing the “high” associated with marijuana use, according to the United States Food and Drug Administration (FDA). However, unlike THC, CBD is not psychoactive.

The US FDA has not approved any drugs containing CBD other than one prescription medicine, Epidiolex, for the treatment of seizures associated with tuberous sclerosis complex, Lennox-Gastaut syndrome and Dravet syndrome in human patients.

Epidiolex is an oral solution also developed by GW Pharmaceuticals.

Malaysia’s NPRA previously said code blue it would consider registering Epidiolex if an application is submitted. The agency said all applications will be assessed and the final decision on product registration will be subject to the decision of the Medicines Control Authority (DCA).

According The edgeMalaysia’s largest pharmaceutical manufacturer, Duopharma Biotech Bhd, is investigating the feasibility of cannabis-related healthcare products.

“We are working with a few parties but it is a chicken and egg situation as we need to understand the regulatory framework to make sure we don’t walk away.

“We have been working with some Australian companies as well as other companies in the region to look at options,” said Duopharma Group Chief Executive Leonard Ariff Abdul Shatar.

Duopharma biotechnologies is the leading local generic drug manufacturer in Malaysia, ranking first in value and volume in December 2021.

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