Tagged with pharma

Pharma Legal Handbook A legal and regulatory guide to cannabinoid drugs, medicinal cannabis and opioids in Singapore. This is an extract from the Pharma Legal Handbook Singapore, available here.   Cannabinoid Drugs 1. Are Cannabinoid Drugs authorized in your country? In general, Cannabinoid Drugs are not authorised in Singapore. The Misuse of Drugs…

Pharma Legal Handbook 1. What is the definition of Rare Diseases in your country? As at the date hereof, there is no legal definition of rare diseases in Singapore. In a press release dated 2 July 2019, the Ministry of Health of Singapore (“MOH”) defined a rare disease as a condition that affects…

Pharma Legal Handbook 1. Are biosimilar medicines considered the same as generic medicines in your country? Biosimilar medicines are not considered the same as generic medicines. According to the Health Sciences Authority of Singapore (“HSA”), biologics are medicinal products with large complex molecules produced by living cells through highly specific processes. Even a…

China Boan Biotech CEO Jiang Hua outlines the Luye Pharma-acquired company’s approach, securing stable revenues through its biosimilars while pursuing novel platforms and innovative drug development. She provides insights into the biotech’s six biosimilar products, as well as its main technology platforms – including the foundational Human Antibody Transgenic Mouse platform…

Korea A roundup of some of the biggest stories from South Korean healthcare and pharma, including the government’s continuing standoff with doctors over medical reform plans; Merck’s plans for a new 300-million-euro plant; EuBiologics’s World Health Organization (WHO) prequalification for its cholera vaccine, and Samsung Biologics’ record Q1 earnings.   South…

France The biggest stories from French healthcare and pharma, including AstraZeneca’s acquisition of Amolyt Pharma; protests over Sanofi layoffs; Pierre Fabre’s purchase of Kinnate Biopharma’s  experimental pan-RAF inhibitor, and French biotech SeaBeLife’s EUR 1.5 million funding round.   Withdrawal of a flu vaccine due to a price dispute between Sanofi and…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport) The policy and regulation of drugs (‘medicinal products’), biologicals and medical devices falls under the jurisdiction of the Ministry of Health,…

Pharma Legal Handbook  1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Ministry of Health and Care Services (Helse- og Omsorgsdepartementet, “HOD”) is the superior administrative authority in Norway, with jurisdiction over drugs, biologicals, and medical devices.   The Norwegian Medical Products Agency (Direktoratet…

Pharma Legal Handbook 16. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? Clinical trials are not required to be conducted in Norway as a condition for obtaining a marketing approval. As part of the application for a marketing approval, the applicant must submit clinical…

Pharma Legal Handbook 22. What is the authorization process for the marketing of new drugs, biologics, medical devices, over the counter medications and other medicinal products? See answer to Chapter 1, question 3.   23. What is the authorization process for the marketing of generic versions of these products? To obtain a marketing…

Pharma Legal Handbook 44. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? Traditional medicine: The main legal framework regarding traditional medicinal products, regardless of whether the product is a prescription-only or non-prescription (OTC) product, is set out in the Medicines Act (LOV-1992-12-04-132) and the Medicines Regulation (FOR-2009-12-18-1839).…

Pharma Legal Handbook  53. What types of liability are recognized in your jurisdiction? Liability under Norwegian law can be distinguished between civil and criminal liability. Criminal liability may be incurred by anyone who violates penal provisions, either in the penal code, or provisions in other acts of legislation which is sanctioned with criminal…