An insight into regulatory reforms in Malaysian Pharma. Prepared in association with Skrine, a leading law firm in Malaysia, this is an extract from The Pharma Legal Handbook: Malaysia, available to purchase here for USD 99.
1. Are there proposals for reform or significant change to the healthcare system?
The followings are some of the regulatory proposals and reforms in the pharmaceutical industry in Malaysia:
- online registration system. In 2017, the NPRA, MOH officially launched the upgraded online registration system, QUEST3+ including a member- ship registration module, a helpdesk module, admin module and cosmetic notification module and offer online payment services;
- online ADR reporting system. In 2017, the NPRA also launched an online ADR reporting system known as ConSERF Online;
- development of the Malaysian herbal monograph. This monograph was established under the National Key Economic Areas and the project has developed 10 herbal monographs which aids in ensuring that the production of local traditional products are safe, of high quality, competitive and comply with international standards;
- In 2006, the Malaysian National Medicines Policy (MNMP) was established to meet the Malaysian healthcare needs. Under this policy the Pharmacy Research Priorities was issued in order to further support the 11th Malaysia Plan, Ministry of Health Strategic Plan 2016-2020 and the Pharmacy Programme Strategic Plan 2017-2010. The report suggested that the areas which are given priority for research are as follows:
a. access to medicines
b. monitoring and evaluation of outcomes
c. quality and safe use of medicine and sustainability
d. optimization of therapy and pharmacy services delivery
e. national databases/big data analytics
the aim of this Pharmacy Research Priorities gives an indication of the areas that will be focused on by individuals and healthcare organisations who conduct pharmacy researches in Malaysia;
- price controls on pharmaceuticals and professional fees to reduce the costs incurred by the population. The Malaysian government published guidelines on professional fees under the Private Health Care Facilities and Services Act 1998 and 2006 Regulations. The Malaysian Medical Association also issued a recommended fee schedule that is now in place as a benchmark for professionals;
- advertisement of medical devices. The MDA has prepared a draft Code of Advertising for Medical Devices with the aim to help the industry and healthcare professional in complying with the Medical Device Act 2012 and MDA’s regulations.
2. When are they likely to come into force?
Many of the proposals and recommendations for the healthcare industry are still in the research and/or discussion stages and we therefore cannot confirm any fixed date for the implementation of any of the proposed reforms. However, the Code of Advertising for Medical Devices is speculated to be gazetted by the end of 2019.