National Pharmaceutical Regulatory Agency (NPRA), Ministry of Health as a secretariat of Drug Control Authority (DCA) is responsible to ensure the quality, safety and efficacy of registered products and notified cosmetics.
Good Manufacturing Practice (GMP) Section, Centre of Compliance and Quality Control is responsible to perform GMP inspection towards local and foreign manufacturing premise consists of:
- Pharmaceutical products (including scheduled poisons, over the counter products and medicinal gases
- Biologics products including Cell and Gene Therapy Products (CGTPs)
- Traditional/herbal products
- Health supplement products
- Cosmetics
The pharmaceutical products, biologics products, traditional/herbal products and health supplements products are regulated as registered products. Hence, the manufacturers are required to apply for a manufacturing licence in order to conduct manufacturing activities. Meanwhile, cosmetics are regulated as notified products and do not require a manufacturing licence prior to manufacturing activities.
For CGTPs, it is regulated by NPRA under the listing programme until the year 2024 and the product requires full registration and manufacturing licence starting in 2025.
The study includes routine on-site inspections of local manufacturing facilities for pharmaceuticals, biologics, traditional/herbal medicines, health supplements, and cosmetics, non-routine on-site inspections of foreign pharmaceutical manufacturing facilities conducted between January to December 2023, excluding manufacturing premises of CGTPs as they are currently under NPRA's listing/voluntary registration program.
The purpose of the study is to analyse major and critical deficiencies observed during routine inspections of local manufacturers and non-routine inspections of foreign manufacturers, identify gaps between industry practices and regulatory expectations, and publish the analysis outcomes for industry reference.
To access the full report, please click here: Deficiencies Analysis Report 2023
Written by: Azraini Abdul Samat, Mohamad Khirul Anuar Mohd Noor, Meera Kumari Ram Navas, Noor Aini Zainal Abidin, Syafiqah Ab Jalil, Wong Kuan Yeen, Yah Xin Yun
