Malaysia’s Drug Registration Guidance Document (DRGD) is a cornerstone for pharmaceutical compliance. The "Drug Registration Guidance Document (DRGD), Third Edition, Ninth Revision, January 2025", issued by the National Pharmaceutical Regulatory Agency (NPRA), Malaysia, serves as the definitive guide for registering medicinal products. The document includes regulatory processes, quality control, inspection, licensing, and post-registration activities.
The DRGD is intended to be used in conjunction with the current laws and regulations governing pharmaceutical and natural products for human use in Malaysia. The scope of this DRGD includes information relating to administrative requirements and procedures for:
Submission of an application for the registration of medicinal products, which is based on the ASEAN Common Technical Dossier/ Requirements (ACTD/ ACTR), where applicable;
Submission of an application for the licensing of manufacturers, importers and wholesalers;
Submission for amendments to a registered medicinal product; and
Post-registration activities.
This DRGD contains five (5) Main Sections and thirty-three (33) Appendices. The main sections are:
a) Section A: General Overview
b) Section B: Product Registration Process
c) Section C: Quality Control
d) Section D: Inspection, Licensing, Certificate
e) Section E: Post-Registration Process
The guidance begins with a General Overview, establishing the legal foundation under the Control of Drugs and Cosmetics Regulations (CDCR) 1984.
It defines key product categories such as New Drug Products, Biologics, Generics, and Natural Products and provides classification frameworks for overlapping areas like Food-Drug and Medical Device-Drug Interphases, ensuring clarity on regulatory pathways.
Additionally, exemptions for clinical trial manufacturing and sample production are clearly outlined, supporting research and development efforts.
The Product Registration Process section details the procedural steps for submission, evaluation, and decision-making by the Drug Control Authority (DCA). It includes evaluation types such as full, conditional, and abridged pathways, catering to different product categories.
Special provisions for Priority Review are available for public health-critical products, such as those addressing pandemics. Furthermore, stringent guidelines for Labeling and Packaging ensure compliance with regulatory standards, including requirements for halal certification, particularly for export markets.
A strong focus on Quality Control (QC) is evident, emphasizing validated analytical methods and the submission of product samples. This ensures the safety, efficacy, and quality of both pharmaceutical and natural products. The section also highlights sampling requirements, ensuring consistency across different product categories. Meanwhile, Inspection, Licensing, and Certificates emphasize the importance of compliance for manufacturers, importers, and wholesalers. This includes obtaining licenses such as
Manufacturing, Import, and Wholesale Licenses, which are integral to the supply chain’s regulatory oversight.
Post-registration activities are addressed in the Post-Registration Process, which ensures ongoing compliance. This includes Pharmacovigilance to monitor adverse events, Product Quality Monitoring (PQM) to maintain product standards through sampling and testing, and detailed procedures for Variations and Amendments, enabling companies to make necessary updates to registered product particulars.
The document also features 33 Appendices covering critical areas like Data Exclusivity, Bioequivalence Studies, and Priority Review. Together, these components ensure that the regulatory environment supports innovation while maintaining stringent safety and quality standards.
For detailed information, download the full DRGD, Third Edition, Ninth Revision, January 2025, on the NPRA website.
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