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Reject Illegal Medicines Roadshow launch

Pharma Supply Chain Resilience Webinar

Global Trend in Pharmaceutical Supply Chains ( by Mr Devaraj Subramaniam, IQivia consulting group)

• Then & now of the current US administration
• Potential implications for the pharma supply
• Pharmaceutical exempted from Tariff currently.
• Potential implication to pharma supply:
• 1. Increase Drug Cost (esp. generics to US) and Shortage (esp in US)
  2. Rising protectionism & local manufacturing
  3. Supply chain rebalancing.

1. diversify export market
2. strengthen regional trade.
3. focus on innovation & value.
4. engage in diplomatic trade dialogue
5. Build resilient local supply chain.

1. Critical challenge
1. Resources (Single source, API imports, Far sourcing)
2. Human capital (brain drain, Foreign labour)
3. R&D ( Access to financing )
4. Logistics ( Port congestion & Increase cost, long delivery cycle. )
5. High dependence on imported pharmaceutical + Stockpile (<1 year)= Vulnerability in supply chain.
2. Critical success factors
1. Manufacture domestically high quality API.
2. Geopolitical diversification of pharma supply chain.
3. Multiple domestic & foreign manufacturers for each product and its precursors.
4. Adequate skilled workers
5. Increase in R&D

1. IPA exports 80% of the country's pharmaceutical.
2. India exports 20% of the global generics.
3. However, around 70% API are coming in from China.
4. Key industry action during pandemic:
1. Fast tract approval
2. Emergency authorization of selected molecules
3. Virtual SEC meeting
4. 3-4 months inventory stock level including API.
5. Alternative suppliers esp from Europe.
6. Digitalization.

Good Regulatory Practice Workshop on Screening Practices for New Drug Products and Biologics

A new screening package will be implemented w.e.f May 2025 which includes:

1. Cover letter & new screening check list to be uploaded to E14 and S10
2. Relevant forms (eg Non clinical GLP certificates E14, FRP E14, POA E12 BE P9 etc)
3. Guidance for industries.

NPRA insists on valid GMP 3 years from date of inspections during screening. The slides will be circulated to members once received.

Annual General Meeting 2025

NPRA consultation Medicine shortage reporting system

1. This procedure is created following the shortage of medicine that happened in 2020, and the recent issue of insulin shortage
2. The scope is of all medicine (pharmaceutical product) including vaccines, which contains Poison for human use. (exclude Vet products)
3. Reporting of medicine shortage and medicine discontinuation. PRH is to report 6 months before shortage / discontinuation. For shortage that happened suddenly, it must be reported immediately
4. Reporting is via google form. Once NPRA gets the report, they will inform other PRH with the same active ingredient to get info if the same product is marketed or not. Please refer to slide no 7 for details on the action taken by NPRA once they receive the report
5. Medicine Shortage Database will be published in NPRA website (public domain), with active database, after directive is being issued out. At the moment, access to the Medicine Shortage Database can only be access through the link in the guidance document (which is still in draft)
6. Regulatory action will be taken for companies that breach mandatory reporting obligations. Please refer to slide no 10 on this matter
7. The draft procedure is open for public comments in UPC until 5 May 25
8. It will then be tabled into Jun DCA meeting, and directive will be issued
9. Implementation will be Jul 25 (voluntary) and Q1 2026 for mandatory implementation

Tariff Impact Assessment on Pharmaceuticals and Medical Devices

The meeting obtained stakeholder's feedback on the impact of the imposition of tariff's by the USA with on-site participation by PhAMA, MOPI, MAPS, Malaysian Medical Device Association (MMDA), Association of Malaysian Medical Industries (AMMI), Association of Manufacturers of Malaysian Medical Device (PERANTIM). Among other organisations that joined via on-line engagements was the Malaysian Rubber Glove Manufacturers Association (MARGMA).

Based on the latest published data (2023), total exports of Medical Devices from Malaysia was RM 37 billion (out of which RM 8 billion was the gloves export), and RM 14 billion was exported to the USA. Hence, the USA is a significant market nearly 40% of the total export market and gloves are a key export (nearly 20% of the total export market).

The AMMI, MMDA & PERANTIM all suggest an increase in cost is likely due to direct costs (increase in export costs due to the tariff ) and indirect costs (as many medical devices exported from the USA require components that are needed to be imported which are subject to tariffs).

As for MOPI, the latest published data (2023) states that total imports of Pharmaceuticals was RM 11 billion whilst the total export market size was RM 2 billion. MOPI expressed concerns that the tariffs will cause an increase in the price of APIs from countries with a relatively lower tariff rate (for eg Metformin API from Norway) as there will be more demand from the USA to import API and there will be less priority for smaller markets like MY, which may also impact medicine security.

Nevertheless, there will be opportunity to import APIs from higher tariff nations (India ; 26% tariff and China ; 104%) as these manufacturers will consider "dumping" their API to non-US nations but there is a possibility of countries that uses these API's may be subject to increased tariff's from the USA (as the USA may perceive this as a backdoor method of bypassing the tariff's imposed on high tariff nations).

TKSU also shared that the USA's method of imposing reciprocal tariff also takes into account "non-tariff trade barriers" such as the MoH's policy of preferring local manufacturers for tender awards, among other policies. He suggests that the MoH may need to revisit these policies in order to lower the overall tariffs imposed on MY.

Finally, TKSU also requested for stakeholders to provide feedback to the MoH by Friday at the latest, to be presented to the honourable Prime Minister next week prior to the discussion with the USA to negotiate the tariff's.

TKSU also reiterated the overall need for the MoH to reduce costs for drug & device procurements, further engagements to align MAPS interest for tender procurements should be made after the tariff's discussion are concluded.

Monash University Pharmaceutical Science Advisory Group 1st 2025 meeting

Public Accounts Committee meeting with Industry

The proceeding was held on 6th March 2025 before the PAC, chaired by Datuk Wira Hajah Mas Ermieyati binti Haji Samsudin together with several members of Parliament who are PAC members. The witnesses called were from MAPS, Phama, MOPI and MPS. MAPS was represented by the President.

Good Governance in Medicines modules discussion

1. Modul pengenalan (Introduction Module)
2. Modul tadbir Urus Ubat-ubatan yang baik(Good Governance fo Medicine Module)
3. Modul Integriti & Etika(Integrity & Ethics Module)
4. Modul Garis panduan keselamatan & pengendalian stok di fasiliti kesihatan & kes sebenar. (Security Guidelines & stock handling in health facilities & actual cases Module)
5. Modul tindakan tatatertib & hukuman(Disciplinary actions & penalties Module)

Public engagement by Public Accounts Committee on the Insurance Premium Hike and Private Hospital Charges

MAPS president attended this meeting which was chaired by YB Sim Tze Tzin together with several other members of Parliament with representatives from the Bank Negara Malaysia and many other government agencies. Over 570 persons attended, with 51 persons from all walks of life who spoke at this session that was held from 9 am to 12.30 pm.

While the President spoke on the general role of pricing and generics in managing healthcare costs, the PAC has extended an invitation for a closed door session in March. We hope to be able to present a more comprehensive position when we attend the session involving the 3 industry associations. Members are encouraged to provide feedback to the secretariat by end of February, to allow time for our views to be fully captured when we meet the PAC.

Technical Committee meeting for DUNas 2025 component 2: Quality , Safety & Efficacy

1. For NPRA to reach WHO maturity level 3, requires 65 institutional development plans (IDP). 56 IDP on going, 19 requires amendment to Sales of Drug Acts 1952. Amendment to SODA already published in UPC.
2. For NPRA to be recognised as ICH members, requires funding. Tabung Amanah L720 set up to receive donation from associations.
3. Cell Gene Therapy registration guidelines to be published in Q2 2025. Currently only 1 product approved. 6 GMP inspections , 1 GLP and 1 CTIL/ CTX.
4. First in human FIH clinical trials. 6 applications received to conduct FIH study locally.
5. NPRA as statutory body idea rejected by MOF. Instead to pursue as Badan Ber-autonomy.
6. Online sales of illegal & falsified medicines a total of 11527 cases in 2024 leads to related advertisement removal in local e-marketplace.
7. Enforcement to reduce sales of unregistered products reduction by 60% achievement.
8. Pharmaceutical Tract and trace (PTTS) to be in 1st phase voluntarily basis for all poison target to start in 2027. July 2025-June 2026 to set up repository system. The company that wins the tender of hologram will be task to set up this repository as well.
9. PV inspections- 9 companies volunteered to be inspected. 2 companies from MAPS passed the inspections. Change of Acts requires to involve mandatory PV.
10. 5 test methods developed locally by NPRA to test vaccines.
11. FRP facilitated registration pathway. NCE:9, Biologics: 6 Generics: 3 approved under this pathway in 2024.

E-Labelling Committee Meeting no. 1/2025

1. Pilot Study on E-labelling second round of data analysis on going and presentation will be held in Mar/April 25.
2. Video of E-labelling will be translated from English to BM. To display at NPRA Facebook page, NPRA website consumer section.
3. 30 biologics, 261 generics and 96 NCEs with a total of 387 products approved for e-labelling.
4. To open to non-association members by July 2025.
5. To expand to OTC by July 2025.
6. Quest 3+ down time in Dec due to hardware issues, measures have been undertaken to prevent such occurrence. Quest 5 will be cloud based.
7. To move "Technical evaluation summary" to another landing page. It is a requirement to publish this for public access.
8. NPRA to discuss internally if bundling of variation is allowed.
9. Wait for study outcome, to decide if DHCP letter is still needed.
10. Cannot share pack with other countries which implement E-labelling due to different QR code used. Future to have 1 international pack, with 1 QR code. Geo-fencing at backend, so that each country will direct to different landing pages. Possible to harmonized within ASEAN. Ideally, ASEAN regulator to accept MY e-labelling.

Technical Committee meeting for DUNas 2025 component 5: Partnership and collaboration for the healthcare industry

Below are a few key points:

1. Disposal of medicines by consumer via community pharmacists MY Medisafe was launched on 25 Sept 2024.
2. Pilot project of E-prescription from KKM facilities to Community pharmacies was started on 2 Dec 2024 within Penang state, with 4 KKM facilities (Hosp P Pinang, Hosp B Mertajam, KK Jln Perak, KK Seberang Jaya) involved with 55 community pharmacies.
3. Based on study, Estimating Community Pharmacists Service Fee, a proposal for service fee of RM6 per repeat prescription was made. RM1 will be paid to ProtectHealth as service purchaser for the purpose of service management of Ubat%40Komuniti which includes training and monitoring of services given by community pharmacies involved.
4. E-pharmacy task force to be formed by MPS - enforcement.
5. Pharmacy Research Priorities Malaysia (2nd edition) was launched by YBMK on 19 Aug 2024. 11 studies published which is collaboration between private-public sector. Mainly by the universities.
6. Regional collaboration strategy for ASEAN Drug Security & Self Reliance (ADSSR) Plan of action to be postponed to May 2025.
7. Tabung Amanah L720 was set up to receive donation from associations or 3rd parties for the purpose of NPRA achieving ICH accreditation. The fund will be used for training purposes.

Technical Committee meeting for DUNas 2025 component 3: ACCESS TO MEDICINES

Technical Committee meeting for DUNas 2025 component 1: GOVERNANCE IN MEDICINES

Engagement session on DG's Directive regarding Poisons Act

1. increase an additional of 7 antibiotics [ Apramycin, Bacitracin, Enramycin, Tiamulin, Trimethoprim, Virginiamycin and zinc bacitracin] under prohibition to sell wholesale for use as food products promoting growth or prophylaxis of animal use by any licensed pharmacists.
2. prohibit to import and /or sell nicotine for manufacturing of cigarette productss by any licensed pharmacists.

Good Submission Practice Workshop

1. Dossier can be submitted for evaluation after getting GMP inspection date only.
2. For study specific BE centre inspection, dossier can only be submitted after 20k payment been made to NPRA.
3. Q2 2025 NPRA will require Quality Overall Summary (QOS) to be submitted in the relevant section.

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

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