Business

Malaysia: National Pharmaceutical Regulatory Agency (NPRA)

The quality and safety of pharmaceutical products are guaranteed by Malaysia’s National Pharmaceutical Regulatory Agency (NPRA). The NPRA website has details on the organization, press announcements, a newsletter section, and a tool for searching for products.

The 3rd revised edition of the guidelines and standards for conditional registration of pharmaceutical products during a disaster has been released by the National Pharmaceutical Regulatory Agency (NPRA) Malaysia in March 2022.

The goals of this guidance are to apply a risk-based strategy to expedite the process of bringing in new pharmaceutical items (including vaccinations) during disasters and to serve as a resource for information for all stakeholders.

The Ministry of Health (MOH) reports that there are currently 27,533 traditional medicines registered with the NPRA.

Applications for conventional products containing active compounds from botanic or animal species, including tigers or rhinoceroses, that are endangered or protected will also be denied.

The NPRA will also disapprove of conventional pharmaceuticals that combine elements of the natural and artificial worlds to produce therapeutic benefits, such as menthol-containing goods.

Despite the use of natural components, some traditional or herbal remedies are not approved by the NPRA because they might contain active substances that are listed under the Poisons Act of 1952 or active ingredients that have negative effects.

For instance, the Drug Registration Guidance Documents (DRGD) classify the active element of the Aristolochia herb as a prohibited ingredient because it may cause kidney toxicity. This substance is utilized in several herbal medicines claimed to treat ailments including arthritis and gout.

Traditional medicine is excluded from sterile preparations, vaccines, compounds derived from human parts, and isolated and characterized chemical substances, according to the Control of Drugs and Cosmetics Regulations of 1984.

Applications for conventional goods that make unconventional claims, including that they treat diabetes and cancer, will also be turned down. The traditional medications must also be produced in facilities that have Good Manufacturing Practices (GMP) accreditation and be supported by references that support the dosage and intake recommendations.

Applications that are filed in this manner and meet the criteria will receive priority review, with a processing time of 70 working days. Conditional registration is valid for one year and may be renewed twice (validity of one year each time).

“Guidance and Requirements on Conditional Registration of Pharmaceutical Products during Disaster, Third Revision, March 2022″ has additional information: Website

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