National Pharmaceutical Regulatory Agency (NPRA) Malaysia and Medical Device Authority (MDA) Malaysia have issued an updated guideline, which is the 4th edition, for the registration of drug-medical device and medical device-drug combination products in October 2021.
The main update is about post-marketing surveillance and the steps involved in managing these cases involving the combination products that are registered with NPRA and MDA.
For adverse drug reaction (ADR) reporting, the reference is the latest edition of Malaysian Pharmacovigilance Guidelines. For registered combination products, the management of the incidents begins with the receival of the incident report, whereby an incident reporting form for combination product is to be filled and submitted to both NPRA and MDA.
The nature of the incident will be assessed and determined, and the agency that is responsible for the following steps will be notified. This will depend on the combination product and the primary agency responsible for the product. For example, for a Medical Device-Drug Combination Product, MDA is the primary agency, and this will be considered a device issue. An investigation report will be submitted to the relevant agency.
The primary agency will provide instructions and follow-up steps if required, and the company involved will be required to submit a report on the actions taken. There are also specific timelines, depending on the characteristics of the incident. For example, for a local event related to the failure of the product or a deterioration in its effectiveness, or any inadequacy in its labelling or in its instructions for use, the timeline to submit the notification or initial report is within 30 days from the discovery.
More details can be found in:
- “Guideline for Registration of Drug-Medical Device and Medical Device-Drug Combination Products, 4th edition, October 2021”: https://portal.mda.gov.my/documents/guideline-documents/1771-guideline-for-registration-of-drug-medical-device-and-medical-device-drug-combination-products-4th-edition-1/file.html