News/Photo

MAPS Dinner 2024 Photos

Award: Honouring Pharmaceutical Services Programme (PSP)'s Leadership in Crisis Management - Pandemic Resilience

Photos of the dinner will be uploaded soon.

Stakeholders Engagement session with NPRA

1. This will involve all products except cosmetics
2. Targeted to implement in Q3 2026
3. Will start the process of selecting the products for PMS based on risk-based assessment in 2025-2026 Q1/Q2. During this period, NPRA will email the PRH the list of products. PRH to ensure complete and updated documents for sections E12, P5.1 and P5.2 are uploaded to Quest 3+ according to the list of products as NPRA will use those documents to test the samples of the selected products. Uploading in Quest 3+ will be done through data cleaning module.
4. Directive for this new type of PMS will be out next month.

1. Currently Method Verification is done for locally manufactured vaccines. For imported vaccines, only evaluation of documents is conducted.
2. As NPRA had a finding during their WHO audit last year, this initiative is taken as a measure to close the finding.
3. NPRA will be building a new laboratory facility in 2027 to carry out method transfer for all vaccines, including imported vaccines.
4. In this Method Transfer and Method Verification, manufacturers are to transfer the method to NPRA and NPRA will use the method to do the testing in the new lab.
5. Targeted to implement in 2027 when the new facility is ready. NPRA will start with testing according to priority. However, "exclude" does not mean forever but just for the time being.
6. For vaccines registered in 2025 and 2026, method verification will be done in 2027. NPRA will provide list.
7. PRH responsibilities are listed out in IMG_2056.
8. Full cooperation from the industry is needed because if the method verification fails, then the product will be rejected.
9. All cost for method transfer and method verification is to be borne by the PRH.
10. Method verification will only be done once for the whole product’s life cycle.
11. Lot release is not method verification. Hence, lot release still needs to be done. But for imported lot release, lot release testing not done.
12. NPRA will update if there are any changes in the future.

Insights into New Guidelines: MOH Medicine Formulary Dossier Submission and Medicine Access Scheme

Site Specific Stability Study meeting

Monash University Pharmaceutical Science Advisory Group meeting

Monash University Pharmaceutical Science Advisory Group meeting met online on 21 October 2024. The terms of reference for the group is to provide expert advice and professional guidance on matters and needs relating to the Pharmaceutical Science Programs (the Programs) at Monash University Malaysia (MUM). The Group will undertake the following activities: Provide an avenue of communication between the University and the pharmaceutical industry, advocating for advancement in pharmaceutical science and the industry. Provide external and professional feedback on the suitability of the undergraduate and postgraduate Pharmaceutical Science curricula to meet the current and emerging needs of the industry. Advise on the educational and training needs and outcomes of the professional internships, including needs related to supervisors. Assist with any relevant course accreditation and recognition matters. Act as a sounding board to assist the development of new ideas and initiatives in support of quality improvements. With this program, the course is targeted towards an industry lean, which will provide potential talents who are much more inclined to the challenges of the industry.

Farewell Lunch for NPRA Director

View Archived News