Tagged with EG

China General manager Guillaume Delmotte explores Ipsen’s strategic initiatives in China, highlighting the importance of innovation, addressing healthcare challenges, and fostering a sustainable, people-centric organization. Delmotte emphasizes the rapid pace of change and the vital role of human connections in driving success.   Moving [our China headquarters] to Shanghai allowed Ipsen…

Mexico Drawing on an industry track record of over 25 years, Fernando Fogarin has recently become the strategic project lead for emerging markets at women’s health specialist Organon. He shares his priorities and the particularities of the Mexican market, discussing the positive impact of the country’s upcoming biosimilars reform; Organon’s efforts…

China A roundup of some of the biggest pharma industry news from China, including Fosun’s bid for Henlius Biotech; the revision of the US’s Biosecure Act to provide more time for cutting ties with China; Baili Tianheng’s second Hong Kong listing; Hasten’s acquisition of asset rights for 14  products from Celltrion,…

Saudi Arabia SAJA Pharmaceuticals is aiming to grow from a regional player to a multinational entity, in line with Saudi Arabia’s Vision 2030, leveraging strong partnerships, technology transfer, and strategic licensing to expand geographically. CEO Mohammed Khalil explains how the Saudi firm prides itself on its agility and commitment to high-quality, accessible…

Saudi Arabia PwC veteran of 20 years and partner in the consulting firm’s strategy arm, Strategy&, Dr Walid Tohme has been directly involved in Saudi Arabia’s healthcare transformation journey since 2016. He discusses the significant progress that has been made since then, including the institutional restructuring to separate regulatory functions from healthcare…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Competences for implementation and enforcement of pharmaceutical and medical devices legislation are shared between three governmental bodies: the Agency for Medicines and Medical Devices (ALIMS), which is an independent regulatory body entrusted with…

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…