NPRA-MAPS Dialogue - 16th November 2018
The NPRA met with MAPS for a dialogue regarding issues and challenges, chaired by the new Director of NPRA, Dr Kamaruzaman bin Saleh. Among the topice covered were
- BE comparator unavailable in Malaysia
- BE study report evaluation for registered products
- BE centre accreditation status
- Stability study report for additional primary repacker/additional packer
- Local Zone IVB stability study laboratories
- Zone II stability study results if the Zone IVB study failed
- Restriction of 2 years shelf life of Traditional Medicine/Health Supplements (TMHS) for the stability study conducted outside Malaysia
- Assay requirement for every active ingredient in TMHS
- Zone IVB stability study requirement for TMHS
- API submission implementation on 1 Jan 2020
- Migration history of variation from Quest 2 to Quest 3+
- Data Cleaning in Quest 3+
- New product submission timeline for correspondences
- Auto logout in Quest 3+
- Stability study requirements for inverted and upright conditions
- Compounding products on sale without regiistration
- Product Registration Renewal of Not Commercially Viable Medicines
- Foreign GMP inspection application
The minutes of the dialogue will be sent to all members once confirmed by the participants.
Malaysian Community Pharmacy Business Forum 3.5 10 Nov 2018
A roundtable dialogue was officially conducted by the Malaysian Community Business Forum (MyCPBF), in collaboration with the Pharmacy Board of Malaysia to scrutinize the pharmacy specialization efforts made and its future. Themed 'The Future of Pharmacy Specialization in Primary Healthcare Services and Community Pharmacy', the dialogue discovered the reality, implementation, and conceptualization of pharmacy specialization following the success of MyCPBF 3.0, themed "Be a Part of the Future: Specialisation in Community Pharmacy"- the previous installment of MyCPBF which consolidates pharmacists and public's perceptions towards pharmacy specialization.
Representatives from organisations include Malaysian Pharmaceutical Society (MPS), Academy of Pharmacy Malaysia, Malaysian Community Pharmacy Guild (MCPG), and Malaysian Dietary Supplement Association (MDSA) and MAPS with with Dr Ramli bin Zainal, Senior Director of Pharmaceutical Services Pharmaceutical Services Division. MAPS President was a guest dialog panellist
For more, please visit the post by MyCBPF
MESYUARAT MAJLIS TINDAKAN SARA HIDUP PERINGKAT KLUSTER KESIHATAN
The Cabinet has reactivated this National Cost of Living Action Council (see News). The executive Committee is chaired by the YAB Deputy Prime Minister. The Council has established 6 clusters of priority focus areas, of which one is the Health Cluster.
One of the oservations was the worrying trend of the rakyat resorting to processed foods which are high in fats, salt and sugar, which have effects on the health of the consumers .
The first meeting of the Health Cluster was held on the 7th November, and was jointly chaired by the Secretary General and Director General of Health.
Engagement on Non-Tariff Measurements (NTMs) with Malaysia Productivity Corporation (MPC)
The Malaysia Productivity Blueprint (MPB) is a national strategy to drive productivity growth over the next three years towards 2020. National Productivity Council (NPC) is the steering committee for MPB and its various initiatives and is chaired by the Prime Minister of Malaysia. NPC leads and provides the right direction at the national level. One of the key thrusts of the MPB is to forge a robust ecosystem for businesses in the country. One of the immediate intiatives was to to review non-tariff measures (NTM) and its procedural requirements that impede business growth, including accelerating the improvement of Malaysia’s logistic performance.
NTMs are policy measures, other than ordinary customs tariffs, that can potentially have an economic effect on international trade in goods, changing quantities traded, or prices, or both. NTMs instruments are any permits, licenses and certificates for export and import of goods imposed by the Ministry and relevant government agencies.
A study showed that 70% of all NTMs in Malaysia was under the Ministry of Health, and this was a clear matter of concern. MAPS had a very lively and honest engagement session with the MPC on this subject on the 24th October.
DISCUSSION ON SETTING UP OF TASK FORCE ON PRP GUIDELINES AT TRAINING PREMISES
A meeting was called by Malaysian Pharmaceutical Society to discuss the subject matter with stakeholders at Wisma MPS on 28th August 2018. This meeting was graced by the Director of Lembaga Farmasi, Tn Hj Mohd Yunos bin Shaari with a contigent of LFM staff. Stakeholders included various Council Members of MPS, Welfare commitee of th Young Pharmacist Chapter, University representatives and industry representatives.
Due to the liberalisation of Provisionally Registerd Pharmacist training, some previously unforeseen issues have surfaced. The lively discussion looked at the need for and the actual working of setting up the said task force.
Stakeholders Consultation on the Proposed Revision of General Practitioners' Charges
Christine Yim representing the MAPS Board, attended a town hall session on "Stakeholders Consultation on the Proposed Revision of General Practitioners' Charges", held at the Health Ministry, on 27th August 2018. It was reported that a visit to the doctor at private clinics nationwide could cost a patient at least three times as much next year.The general practitioners' charges of between RM10 and RM35 are to be increased to between RM35 and RM125.
Meeting with Institute for Biotechnology and Medicine Industry 1st Aug 2018
A delegation of 3 from Institute for Biotechnology and Medicine Industry (IBMI) called on MAPS to explore possible partnership. Resulting from the meeting, MAPS members have been invited to visit the 2018 Taiwan Healthcare+ Expo. Further details can be obtained from 2018 Taiwan Healthcare+ Expo. An email to CEO's will ensue
White Paper on SelfCare in Malaysia 13th July 2018
MAPS members were invited to a discussion on the white paper by PhAMA. PhAMA has done a preliminary study to understand behaviors from key stakeholders in understanding SelfCare in Malaysia and are embarking on next step to work on a strategic road map and action which will lead to this White Paper.
MAPS members received a brief report on the study and were invited to be stakeholdes in future endeavours towards SelfCare
MAPS 7th Annual General Meeting 20th March 2018
The 7th AGM was held on 20th March 2018. The Board of Directors for the term 2018 (20th March) – 2021 was also elected. Members present received and approved the Annual Report and Statement of Account, 2017. Issues and challenges affecting the Industry were also discussed. Moving forward, the President urged members to continue to be active as the “strength of MAPS is as strong as the members’ engagement and contribution. Please visit the About MAPS page and scroll down for the latest board members.
Dialogue: 19th March 2018
MAPS President, Mr Lim Teng Chyuan presided in a dialogue on 19th March 2018
Pharmacy Revolution 4.0
On 11th March 2018, the President, Mr Lim Teng Chyuan and the Executive Director, Dr Choe Tong Seng participated in a Seminar with the Theme: Pharmacy Revolution 4.0. It was organised by the Malaysian Community Pharmacy Guild (MCPG). Industry Revolution 4.0 is expected to challenge and disrupt the business model of tradition business and the competitive landscape.
Draft: Code of Ethics for Pharmacists 2018
MAPS, led by the President and four other members, attended the Session on “Draft: Code of Ethics for Pharmacists 2018”, organised by the Lembaga Farmasi, on 2nd March 2018 in the NPRA meeting room. It was a lively discusiion on the contents of the draft. This draft once approved by the Lembaga Farmasi will replace the existing Code of Conduct for Pharmacist.
DUNas 2018 Steering Committee Terms of Reference meeting
The objective of the National Medicines Policy (Dasar Ubat Nasional -DUNas) is to promote equitable access and rational use of safe, effective and affordable essential medicines of good quality
to improve health outcomes of the people. It is a five year policy implementation involving government and private stakeholders aimed at achieving positive outcomes and transformation such as establishing a comprehensive regulation system, strengthening of the laws and regulations, creating a robust pharmaceutical industry as well as developing an extensive pharmaceutical distribution network.
This steering committee is for the monitoring and evaluation of the progress in achieving the initiatives of the framework established in the DUNas Core Action Plans. A meeting for this committee was chaired by the Director General of Health, Malaysia Datuk Dr. Noor Hisham bin Abdullah at Putrajaya on 26th February. The President of MAPS represented the association in this meeting of stakeholders.
The Associated Chinese Chambers of Commerce and Industy Malaysia Chinese New Year Grand Dinner
The Associated Chinese Chambers of Commerce and Industry of Malaysia (ACCCIM) is the national level organisation of the Chinese chambers of commerce in the country. MAPS has had engagements with the organisation on matters of national importance. ACCCIM invited MAPS for its Chinese New Year Grand Dinner Feb 24 2018 at the Setia City Conventon centre, with the YAB Prime Minister as guet of honour.
Workshop: Updates on API, BE and LAB on 18th January 2018
A 1-day Workshop Updates conducted by 6 Regulatory Officials from the NPRA attracted 39 participants from 23 member Companies. This Workshop was very profitable and many had learnt from the knowledge shared and definitely would enhance successful dossiers submission at the first attempt. Congratulations to all participants. Heartfelt thanks to GS Beh, SM Chong and Tammy Lim for successfully organised this Workshop.
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