PharmaBoardroom - Skrine

Skrine is one of the largest and leading legal firms in the country, with a sterling global reputation, and a wide range of highly-regarded practice groups. The firm is currently led by 49 partners with over 110 lawyers. Skrine is the exclusive Malaysian member of Lex Mundi, a network of leading independent law firms in over 160 jurisdictions around the world and the Pacific Rim Advisory Council, a network of 30 top tier independent member law firms. The Firm has been named as the Malaysia Law Firm of the Year in 2020 by Chambers Asia-Pacific; Malaysia Firm of the Year 2013 – 2020 by Who’s Who Legal; ranked as Leading Firm by Chambers Asia-Pacific 2011- 2021; ranked as Top Tier Firm by Legal 500 Asia-Pacific from 2014 – 2021; recognised as leading international arbitration firm since 2012 by Global Arbitration Review (GAR) 100 and have been named as Malaysian Firm of the Year for 2014 – 2016 by Managing Intellectual Property (Managing IP).

Related Articles

Cannabinoid Drugs, Medicinal Cannabis and Opioid Drugs

08/10/2021

Skrine

Malaysia

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 GBP 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…

Regulatory Reforms

08/10/2021

Skrine

Malaysia

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 GBP 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: i) online registration system. In 2017, the NPRA, MOH officially launched the upgraded online registration…

Patents and Trademarks

08/10/2021

Skrine

Malaysia

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 GBP 99. 1. What are the basic requirements to obtain patent and trademark protection? Patent and trademark laws in Malaysia are mainly codified in statutes, but its jurisprudence is derived from the United Kingdom’s common law. Thus, there are similarities between the two jurisprudences,…

Product Liability

08/10/2021

Skrine

Malaysia

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 GBP 99. 1. What types of liability are recognized in your jurisdiction? Product liability for medicines can arise through several grounds of action. These include liability arising from the tort of negligence or strict liability or from breach of contract. Since 1999, the Consumer Protection…

Traditional Medicines and OTC Products

08/10/2021

Skrine

Malaysia

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 GBP 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…

Marketing, Manufacturing, Packaging & Labeling, Advertising: Malaysia

08/10/2021

Skrine

Malaysia

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 GBP 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…

Preclinical & Clinical Trial Requirements

06/10/2021

Skrine

Malaysia

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 GBP 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…

Regulatory, Pricing and Reimbursement: Malaysia

06/10/2021

Skrine

Malaysia

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 GDP 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…