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USA In 2025, just 318 US biotech deals closed in Q2 – the lowest in a decade – even as mega-rounds propped up total investment volumes. For a sector that was booming during the pandemic era, the contrast could not be starker. Leaders from trade organisations and innovation accelerators agree on…

Pharma Legal Handbook Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The primary HTA authority is the Saudi Food and Drug Authority (SFDA), which hosts a dedicated HTA/Economic Evaluation Unit established in 2023. Its main responsibility is to evaluate clinical and economic evidence (EES) for: New…

Global In a pharma industry increasingly squeezed by falling legacy revenues, political pricing crackdowns, and the need to deliver the next wave of science at speed and scale, the right leadership is crucial. Four of the Top 25 global pharma companies – Novo Nordisk (ranked 10th), GSK (12th), Takeda (14th), and…

Pharma Legal Handbook 1.Price Control How does price control at ex-factory prices work in your country? Ex-factory prices are strictly regulated by the Saudi Food and Drug Authority (SFDA) using External Reference Pricing (ERP). SFDA sets a Ceiling CIP price based on the lowest value from a basket of 34 reference countries. Manufacturers…

Africa Africa accounts for 19 percent of the world’s population and one-quarter of the global disease burden. However, for a host of reasons – both real and perceptual – the continent does not yet play host to meaningful levels of clinical research, accounting for just 1.1 percent of all clinical trials…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Health Canada is the federal authority responsible for regulating pharmaceutical drugs, biologicals, and medical devices for human use. Health Canada’s Health Products and Food Branch (“HPFB”) is the body responsible for reviewing, assessing,…

Pharma Legal Handbook 16. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? There is no requirement to conduct local trials of a new drug to receive marketing approval. Rather, in order to obtain marketing approval, a company must submit an NDS application containing information…

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? The authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products are mentioned in Chapter 1, Question 3: What are the steps…

Pharma Legal Handbook 44. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? In Canada, traditional, herbal, complementary or alternative medicines are included under the previously defined term “NHPs.” NHPs are governed by the Food and Drugs Act and the Natural Health Products Regulations, which provide requirements concerning…

Pharma Legal Handbook 53. What types of liability are recognized in your jurisdiction? In general terms, product liability arises from claims in contract or civil wrongs under the common law or civil code, depending on the province. Plaintiffs can hold manufacturers concurrently liable in either contract or civil wrongs.   Contractual Liability Plaintiffs…

Pharma Legal Handbook 58. What are the basic requirements to obtain patent and trademark protection? In order to obtain patent or trademark protection, one must submit an application to the Canadian Intellectual Property Office (“CIPO”) and comply with the formalities of the application process set out by the agency. All forms and guidelines…

Pharma Legal Handbook 66. Are there proposals for reform or significant change to the healthcare system? There are three significant changes which are currently evolving that will impact healthcare in Canada in the future.   National Pharmacare As of October 10, 2024, Canada adopted the Pharmacare Act which seeks to provide a national…