08/10/2019
Cannabinoid drugs, medicinal cannabis and opioid drugs in Malaysia – a comprehensive legal overview. 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. CANNABINOID DRUGS 1. Are Cannabinoid Drugs authorized in your country? The Malaysian regulatory authority does not authorise the use or sale of any specific drug per se, i.e. cannabinoid drugs, rather it regulates the registration of products which may…
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+…
The key facts about patents and trademarks 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. What are the basic requirements to obtain patent and trademark protection? The Malaysian jurisprudence on patent and trade mark protection is derived from the United Kingdom’s common law and mainly codified in statutes. Thus, there are similarities between the two jurisprudences, including…
All legal aspects surrounding product liability 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. What types of liability are recognized in your jurisdiction? Violation of laws and regulations may result in civil liabilities, administrative penalties and criminal liabilities Civil Liability discontinuance of infringements; restitution (restoration of original condition); specific performance; compensation for loss; payment for breach of…
A brief overview of the situation regarding traditional medicines and OTC products 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. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Alternative medicine is regulated by the Traditional and Complementary Medicine Council (“TCM Council”) established under the Traditional and Complementary Medicine Act 2016 (“TCMA…
All about marketing, manufacturing, packaging & labeling, advertising 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. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? Although it is common for the marketing authorisation of medicines and devices to vest in the PRH, this is not necessarily…
06/10/2019
The low-down on the situation regarding preclinical & clinical trial requirements 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 clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Malaysia is actively developing its capability in all phases of clinical trials and there is currently no mandatory condition for clinical…
An intro to the legal situation for regulatory, pricing and reimbursement in Malaysia. 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. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health (MOH) is the primary governmental body responsible for the health of the people and the overall healthcare…
