Tagged with M

Pharma Legal Handbook 1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, there is no requirements for clinical trials to be conducted locally as a condition for marketing approval.   2. How are clinical trials funded? Clinical trials are funded by the sponsors.…

Pharma Legal Handbook 1. What is the authorization process for the marketing of new drugs, biologics, medical devices, non-prescription medications, and other medicinal products? As outlined in the answer to question 3 in Chapter 1, marketing authorisation of medicinal products (including new drugs and biologics, regardless of the manner of reimbursement) may be…

Pharma Legal Handbook 1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicines are subject to a marketing authorization issued by ALIMS. Marketing authorization is not required for traditional herbal medicines or homoeopathic medicines which fulfil conditions prescribed in the Medicines Act. Instead, they are registered…

Pharma Legal Handbook 1. What types of liability are recognized in your jurisdiction? In Serbia, there are two parallel regimes of product of liability applicable to medicinal products. The first one is established by the Obligations Act of 1978 (as amended), while the second type is prescribed by the Consumer Protection Act of…

Pharma Legal Handbook 1. What are the basic requirements to obtain patent and trademark protection? Under the Patent Act (Official Gazette of the Republic of Serbia, nos. 99/2011, 113/2017 – other act, 95/2018, 66/2019 and 123/2021), in order to obtain patent protection for an invention, the invention must satisfy the basic requirements of…

Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? There is an overall tendency by the Government to improve the healthcare system in Serbia, especially through digitalization and investments into creating conditions for biotechnology and innovative therapies. Regarding legislative changes, a new medicines act has been…

Pharma Legal Handbook Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? Yes, cannabinoid-based medicines may be authorised, under the requirements prescribed by the relevant legislation. Cannabinoid-based substances are classified as the psychoactive controlled substances that are regulated by the Psychoactive Controlled Substances Act (“Official Gazette of the Republic of Serbia”, no.…

China Writing exclusively for PharmaBoardroom, Song Ruilin of the China Pharmaceutical Innovation and Research Development Association (PhIRDA) outlines some of the key improvements and optimisations in the regulatory landscape for pharmaceutical innovation in China. Professor Song also notes the major impact that Chinese innovation is having on global R&D pipelines and…

Saudi Arabia As Managing Director for Healthcare at Accenture Middle East, Samar Nassar oversees the global consultancy’s healthcare practice in the region, focusing on end-to-end management of large clients in both public and private sectors. Nassar highlights some of the key healthcare trends and challenges in the region, including workforce shortages, mental…

Saudi Arabia Mostafa Nagib outlines Lundbeck’s strategy and growth in Saudi Arabia, emphasizing their dedication to neuroscience and expanded access to innovative treatments. He discusses the challenges in mental health awareness and stigma as well as the journey of transforming Lundbeck Saudi to adapt to the Kingdom’s rapid development, fostering an environment…

Europe As the EU’s push to harmonise clinical assessments across its 27 member states moves from the initial Health Technology Assessment (HTA) regulation in 2022 to the European Joint Clinical Assessment (JCA) process that will come into effect in January, European HTA authorities and industry leaders weigh in on the implications.…

Global Writing in the June 2024 edition of ISPOR’s Value in Health journal, Nancy J. Devlin, PhD, Michael F. Drummond, MCom, DPhil, and C. Daniel Mullins, PhD look back on the history of QALYs in cost-effectiveness analysis and policy decision making, and why the backlash against QALYs in the United States…