Tagged with ARM

Japan A roundup of the most important stories coming out of Japan’s pharma industry, including the sharp increase in deaths linked to Kobayashi supplements; the partnership between Moderna and Mitsubishi Tanabe to jointly promote Moderna’s mRNA respiratory vaccine portfolio; the country’s move to to support domestic antibiotics production; Takeda’s licenscing agreement…

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,…

Italy Some of the biggest pharma and healthcare stories coming out of Italy, including Italy’s antitrust investigation of Novartis and Genentech; Johnson & Johnson’s EUR 125 million investment in its Italian manufacturing site; Chiesi Farmaceutici’s licensing agreement with Gossamer Bio for a pulmonary hypertension drug, and Menarini and Insilico’s oncology partnership.…

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…

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.…

Hong Kong Managing director of Otsuka Pharmaceutical Hong Kong Koji Ueda explains the Japanese company’s long-standing presence in Hong Kong, which dates back to 1956, the affiliate’s 50-50 split between pharmaceuticals and nutraceuticals and within pharma its principal focus on nephrology and CNS. Moreover, he explains the milestone launch of Otsuka’s first-in-class…