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E-Labelling Bil 2nd Meeting 2024

On 26 Mar 2024, 9am, MAPS attended another E-labelling Discussion on the proposal to conduct a study on "Impact of E-labelling implementation on Pharmaceutical on the Public, Healthcare Professionals & Industries" by DR June Choon from Center for Drug Policy and Health Economic research (CDPHER) Faculty of pharmacy, University Teknologi Mara. This study has been extended to cover public over the age of 18 years old, Health Care Providers (HCP), Associations like MMA, MPS and Malaysian Nursing Association plus industry's Regulatory Affairs personnel.

A video has been produced which will be launched soon to educate public and HCP on how to scan the QR code to retrieve the E-labelling. This meeting was chaired by YBrs. Puan Rosilawati binti Ahmad, Chairman of committee for e-Labelling.

Training on Government Procurement Policy by MOF

On 21 Mar 2024, 2pm a training has been conducted on Government Procurement Policy by En Wan Azwar Zaihan bin Wan Ahmad, from Government procurement International Negotiation Section under Government Procurement Division, Ministry of Finance; pertaining to CPTPP (Comprehensive and Progressive Agreement for Trans-pacific Partnership). A total of 51 staff from among our members attended the training. This training was made possible following our engagement with the Deputy Secretary General (Finance) of the Ministry of Health, Dato Sri Norazman Ayob.

Annual General Meeting 2024

The 13th AGM was held in the morning of 21st March 2024 with a quorum of 26 companies (70%). The Board of Directors for the term 2024 (21 March) – 2027 was also elected. Members present received and approved the Annual Report and Statement of Account, 2023. Issues and challenges affecting the Industry were also discussed. The President urged members to have active discussions within the company when received email notifications from MAPS. Please visit the "About MAPS" page and scroll down for the latest board members.

The Board and President thanks all members who attended the AGM and their unwavering support. The Board also thanks our gracious host Medispec and Dr Choe for his many years of service as Executive Director guiding us from strength to strength.

Partnership and Collaboration for the Healthcare Industry Component of DUNas technical committee meeting

MAPS attended DUNas component 5: Partnership and Collaboration for the Healthcare Industry on 19 March 2024 9am to 12 pm. The Deputy Director of NPRA, Dr Azuana binti Ramli chaired this meeting. The status of 8 strategies and 9 initiatives were updated. The Pharmacy Services Program may call for a mid-term review sometime in quarter 3 this year.

New Deal for Business Validation meeting

Following the engagement session with the Economy minister, a validation session was held on March 15th at Zenith Hotel, Putrajaya. The first item on the agenda was the validation of the pharmaceutical industry on Quest 5 and formulary.

Quality Use of Medicine Component of DUNas technical committee meeting

MAPS attended DUNas component 4: Quality Use of Medicine on 14 March 2024 9am to 10am. This meeting was chaired by En Mohd Zawawi bin Abdullah, Director of Pharmacy Enforcement. 4 strategies, 11 initiatives and 14 indicators were presented. The 4 over-arching strategies are on:
  1. Prescribing & dispensing
  2. Pharmaceutical care practices
  3. Community Empowerment
  4. Combating antimicrobial resistance

Engagement session with Economy Minister on the New Deal for Business

The Government is in working towards increasing investor confidence, trade and competitiveness as well as stimulating economy through the implementation of the New Deal For Business (NDFB).

The main purpose of NDFB is to simplify business transactions and support the national digital transformation. This is expected to directly increase the country's productivity and position Malaysia among the 12 most competive nations in the world.

NDFB will focus on structural reforms and improving the processes and procedures to counter bureaucracy, inefficient regulations and inappropriate bureaucratic burdens for investors and businesses.

For more information on this do visit this report.

The President and Vice President attended this engagement session with the Economy Minister, YB Rafizi Ramli at Palm Garden Hotel, IOI City, Putrajaya on the afternoon of March 13 2004.

Assess to Medicines Component of DUNas technical committee meeting

On 8 March 2024, MAPS attended DUNas meeting on Assess to Medicines (component 3), chaired by Puan Wan Noraimi binti Wan Ibrahim (Director, Pharmacy Practice and Development). 5 Strategies, 15 Initiatives and 17 Indicators were presented. Budget for Quest 5 has been released end of last year and NPRA will proceed to working on Quest 5 with MAMPU (MALAYSIAN ADMINISTRATION MODERNIZATION AND MANAGEMENT PLANNING UNIT, PRIME MINISTER'S DEPARTMENT) first then only with the industry later in early 2025.

Quality, Safety, Efficacy Component of DUNas technical committee meeting

On 5 March 2024, DUNas meeting component 2: Quality, Safety & Efficacy meeting was held and chaired by Puan Rosilawati, Director of the National Pharmaceutical Regualtory Agency. 25 Strategies, 53 Initiatives and 80 indicators were presented. Most of the indicators were achieved, with the exception of:
  1. ICH status - Unable to fulfill 2x per year of meeting and unable to pay the membership fee of RM200k
  2. NPRA to be a statutory body. This is awaiting confirmation from MOH if policy allowed.

Pre-meeting with NPRA Generics unit

On the 4th March 2024, below issues were discussed and MAPS are to come out with a proposal or comment by 5 April to NPRA. 28 MAPS RAs attended the virtual discussion. The issues in this meeting are
  1. Review on Small Label Criteria
  2. In-use Stability for Multi Dose Liquid Preparation
  3. Container Closure System for Dangerous/Cytotoxic Drug
  4. Elemental Impurities in Pharmaceutical Products
  5. Technical Summary Report (TSR)/ Public Assessment Report for Generics/hybrid
  6. Updates on the use of TiO2

Governance in Medicines Component of DUNas technical committee meeting

The Technical Committee for component 1 of DUNas Term 4, met on 26th February 2024. The achievements laid out in the Master Action Plan for the component of Governance in Medicines was presented. It was chaired by the Pharmacy Services Program Director of Policy and Strategy, Puan Siti Aisah binti Bahari. MAPS was represented by the President at this meeting.

Dasar Ubat Nasional (DUNas) or the National Medicines Policy is the Government and stakeholders' commitment towards achieving the medium and long term goals of pharmaceuticals in the nation. DUNas is in its' fourth term (2022-2026) and the Master Action Plan has been developed, approved by the DG of Health and is being implemented.

This component has 4 strategies, which are implemented via 6 initiatives. The strategies are

  1. To foster a cuture of ethical behaviour
  2. To encourage transparency, accountability and ethical practices amon health care professionals
  3. To strenghten laws and regulations
  4. To improve the capacity and capability of human capital
For a more comprehensive understanding of the National Medicines policy, do download it here. Do note that this document is only in Bahasa Malaysia. Please discuss it with your staff if you need to understand it further in English.

Pembentangan Pencapaian Pelan Tindakan Induk (PTI) DUNas Penggal Keempat bagi Komponen Governance in Medicines

Patent Linkage Meeting 23 Feb 2024

On 23 Feb 2024 9am, 5 Regulatory Committees of MAPS were represented in the discussion on Patent Linkage together with MOPI and TWN (Third World Network). This meeting is chaired by Puan Rosilawati. The industry and TWN reinforced that according to article 18.53 of CPTPP agreement stated that
  1. a system to provide notice to a patent holder prior to the marketing [and not prior to registration] is needed. Therefore there should not be a time frame of 18 months stated in the guidelines to register a generic. Time frame should be open or not to have timeline at all.
  2. There should not be a rush to implement patent linkage by July 2025, when in fact we are given 4.5 years to implement patent linkage.
  3. Since notification is required before marketing, there is no need for generics players to fill in form 1 to 3 prior to screening and obtain acknowledgement from patent holders.
Generics industry is given a time frame until 29 March 2024 to come out with a different proposal than what has been agreed earlier with PhAMA.

Malaysian National Medicines Policy Implementation Committee Meeting

DUNas or the Malaysian National Medicines Policy was drafted to prioritize the medium to long-term goals for the pharmaceutical sector.

In summary, Pn Norhaliza, Director of Pharmacy Service Program chaired the meeting for the 4th Term of DUNas (2022-2026) , to keep abreast of the developments/ implementation of the action plan to ensure that policy is on the right track.

There are 5 components are as below and includes various initiatives to encourage the equitable access of medicines as well as the rational use of medicines that are safe, efficacious, of high quality and affordable to improve health outcomes of the population.

  1. Governance in Medicines
  2. Quality Safety and Efficacy in Medicines
  3. Access to Medicines
  4. Quality Use of Medicines
  5. Partnership and Collaboration for the Healthcare Industry

These topics can be good starting points for discussions to align MAPS interest to ensure our common goals are met.


As a follow up meeting with the MPC 2 days earlier, a larger meeting of associations across multiple sectors was called. This was hosted by PEMUDAH at Putrajaya. The purpose of this engagement was towards the formulation of the document for New Deal for Business (NDFB) which is aimed at improving business confidence, increasing productivity and competition, stimulating economic expansion and supporting the nation's digital transformation. The implementation of NDFB will impact investments, both foreign and domestic, create jobs and increasing the GDP. NDFB is aligned with the MADANI economy to position Malaysia among the 12 top conpetitive markets worldwide.

The NDFB shows the commitment of the government in solving issues to improve the business environment by managing structural and situational challenges. Focus on structural reform to address bureaucracy, efficient rules and inappropriate regulatory burdens. The 10 pain-points identified based on the World Bank study, to be addressed are shown below.

The detailed methodology handbook is available for download by following this link.

Malaysia Productivity Corporation meeting for New Deal for Business

On 31 Jan 2024. MAPS met up with Malaysia Productivity Corporation to discuss issues and challenges with regards to doing pharmaceutical business in Malaysia. MPC will be setting up a Nexus to improve the productivity and efficiency of the industry. Following this meeting, MAPS was invited to an engagement session with MPC on 2 Feb 2024 to formulate New Deal for Business (NDFB) to increase confidence to do business, to improve productivity and competitiveness, to stimulate economical growth and enhance digitalization transformation in the country.

Video Conference with Pharmaniaga Higher Management Team

On 30 Jan 2024 3pm, MAPS BOD has a video conference with Pharmaniaga higher management team on the new APPL contract’s new Clause 4.9.2 2 Return of Products with Shelf life and Clauses 11.2.2 & 11.2.3 Invoice and Payment of the Products. MAPS sought for priority in payment and highlighting the difficulties MAPS members faced and the financial pressure should these clauses be imposed. Pharmaniaga assures that these clauses are meant for pandemic related products and not for normal pharmaceutical products and they have no intention to delay payment. Meeting ended in a cordial mode for both.

Joint Industry Meeting on E-Labelling

On 29 Jan 2024, NPRA held a joint industry meeting on E-Labelling, chaired by DR Azuana binti Ramli, who was pleased with the progress of E-labelling in line with the MOH aspiration in digitalization. MAPS participated in the discussion together with PhAMA and MOPI. 129 products out of 262 applications approved for E-labelling to date. We discussed on the way forward for a survey on the effectiveness of E-labelling to be published in 2 years time. NPRA hoped to achieve private public partnership with the study and to have a good documentation of the process of E-labelling in Malaysia.

MCPG's Business Insight Seminar on Rx Success – How To Pivot in Times of Uncertainty?

On 10 Dec 2023, MAPS attended Malaysian Community Pharmacy Guild, MCPG's Business Insight Seminar on Rx Success – How To Pivot in Times of Uncertainty? Learning on how to embrace changes and make necessary adjustment to thrive in this trying times for all community pharmacists.


MAPS RAs attended the virtual meeting on Biosimilars guidance documents on 25 Oct 2023. Feedback and responses from NPRA were presented, as well as highlights on issues with regard to biosimilars that require further discussion. New guideline will be implemented by Dec 2023.

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