Tagged with Regulator

Global 2023 may have been a breakthrough year for cell and gene therapies with the FDA approving a record of seven novel treatments, but 2024 did not fall behind in the number of greenlit therapies. With seven new approvals and three expanded indications, the cell and gene therapies authorized by the…

USA Peter Marks, the US FDA’s top official for vaccines and cell and gene therapies, has resigned. A survivor of the first Trump administration, when his office faced intense pressure to fast-track COVID vaccine approvals, Marks reportedly clashed with new Health and Human Services Secretary Robert F. Kennedy Jr. and his…

Pharma Legal Handbook Are there any Managed entry agreements in place in your country? (If so, please list them) No.   For each Individual Managed entry Agreement Describe the fundamentals of the Managed entry Agreement, its rationale and the process for implementing it. N/A   When should this Managed Entry Agreement be considered?…

Pharma Legal Handbook Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? In Japan, it is important whether a drug or medical device is covered by the NHI (i.e., whether it is listed on the NHI Price List). If it is, the product is eligible for NHI…

Japan Japan’s amended Cannabis Control Law now permits the development and medical use of cannabis-derived drugs, particularly CBD-based treatments, while simultaneously criminalizing self-use of smokable cannabis products. Writing in the February 2024 edition of DIA’s Global Forum magazine, Toshi Tominaga of Keio University explains why, despite aligning with evolving international regulations,…

Europe The EMA’s Pre-Accession Assistance Program (IPA) helps EU candidate and potential candidate countries align their medicines regulations with EU standards through training, capacity-building, and policy support. As a new op-ed in the February 2025 edition of DIA’s Global Forum magazine outlines, an impact assessment of IPA II (2020-2023) showed significant…

Global In an era of rapid scientific breakthroughs, global regulators are navigating new challenges—accelerating approvals, harmonising standards, and integrating digital tools—while balancing safety, efficacy, and access. Throughout 2024, PharmaBoardroom spoke with regulators worldwide to uncover the key regulatory trends shaping the future of healthcare in 2025 and beyond.   The Road…

USA While the year’s tally of green lights from the FDA’s Center for Drug Evaluation and Research (CDER) is lower than the previous year’s, 2024 saw several long-awaited therapies reach the finish line. Oncology remained the single largest focus area among last year’s endorsed therapies and as opposed to 2023 when…

India Shagun Sharma, Vipul Kumar Gupta, and Helene Sou of Takeda, writing in the December 2024 edition of DIA’s Global Forum magazine, look at how updates to India’s regulatory framework for pharmaceuticals are impacting the industry.   Since 2001, the regulatory environment for clinical research and drug development in India has…

USA For those concerned that opinion and not science may determine US public health policy under president-elect Trump, the choice of surgeon Martin Makary as head of the FDA may be reassuring. While Makary is known as a healthcare critic, his views appear to be far less extreme than the controversial…

USA As Donald Trump assembles his new government, speculations about the consequences of his second presidential term abound. For the life sciences industry, the US president-elect’s more business-friendly stances could entail the repeal of the much-debated Inflation Reduction Act (IRA) while the naming of vaccine sceptic Robert F. Kennedy Jr as…

Mexico With the naming of Armida Zuñiga as head of the country’s regulatory body COFEPRIS, new Mexican president Claudia Sheinbaum has concluded the new government’s healthcare appointments and begun advancing her agenda by tackling Mexico’s widespread medicine shortages.   New Regulatory Lead By the time Claudia Sheinbaum was sworn in as…