Tagged with regulatory,

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…

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…

Europe Vikas Krishan, chief digital business officer at the global data and digital engineering solutions firm Altimetrik, outlines the implications of the European Union’s forthcoming AI Act for the pharma industry and urges for the need to adopt a proactive approach in evaluating AI roadmaps and governance.   The pharmaceutical industry’s…

Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The key regulatory authority with jurisdiction over drugs, biological and medical devices in Singapore is the Health Sciences Authority (HSA). It was established on 1 April 2001 as a statutory board of the…

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…

Global 2023 was a breakthrough year for cell and gene therapies. The field saw a record number of FDA approvals, as other promising therapies in a broad range of therapeutic areas progressed through the pipeline. 2024 looks to be another important year with up to 17 new therapies poised for regulatory…

Europe PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient advocates, industry representatives, and service providers in attendance were treated to a three-day buffet of engaging panels and townhalls with…

Denmark Taken from PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on the HTA decision analysis framework in Denmark. Buy The Pharma Legal Handbook: Market Access & HTA – Denmark here for £359.   Which are the health technology assessment (HTA) evaluation…

Switzerland For the Swiss Agency for Therapeutic Products (Swissmedic), one of the world’s leading regulatory authorities, 2023 was an important year. Not only did the agency gain recognition from the World Health Organisation (WHO), Swissmedic also saw a Good Manufacturing Practice (GMP) agreement between Switzerland and the US FDA come into…

USA The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) approved no less than 55 new drugs in 2023, a number surpassing that of 2022 by almost 50 percent. While 28 rare disease treatments and five novel gene therapies got the green light, the agency also…

Japan Toshi Tominaga of Keio University Hospital, writing in the January 2023 edition of the DIA Global Forum magazine, outlines some recent updates to Japanese drug registration legislation, including how domestically generated academic clinical data can be utilised.   Japan’s current regulatory framework for investigator-initiated trials (IITs) of drug candidates seems…