Tagged with Regulator

Switzerland Raimund Bruhin discusses Swissmedic’s participation in cross-border regulatory initiatives such as the Access Consortium and Orbis and its efforts to support the Global South in developing regulatory standards. Bruhin also addresses the regulatory challenges posed by new technologies, such as Advanced Therapy Medicinal Products (ATMP), and Swissmedic’s strategic objectives, especially…

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…

India US FDA India Office Director Sarah McMullen discusses the importance of maintaining India’s role as a global supplier of low-cost generics while also navigating the complexities of innovating and producing more complex pharmaceutical products. She notes that increased product complexity will inevitably lead to more regulatory challenges, emphasizing the need…

Africa Medicines for Africa’s Lenias Hwenda argues that the success of the much-talked-about African Medicines Agency hinges on a critical mass of African national regulators achieving WHO Level 3 maturity status. While acknowledging the importance of international actors in making this happen, Hwenda argues that – if the African Medicines Agency…

China In 2023, the first full year after the COVID-19 pandemic, the National Medical Products Administration (NMPA) set a new record by approving the highest number of new drugs in China in a single year, write Chunrong Yu of Gracell Biotechnologies and Xu Wang of Novo Nordisk (China) Pharmaceuticals in the…

Europe The EMA’s Peter Arlett looks back on two years of the Accelerating Clinical Trials in the European Union (ACT EU) initiative which aims to improve the environment for clinical trials in the EU by transforming how trials are initiated, designed, and run. In conversation following DIA Europe 2024 in Brussels,…

Japan In conversation at DIA Europe 2024 in Brussels, Shinobu Uzu of Japan’s regulatory agency, PMDA, laid out the organisation’s new five-year plan, how PMDA is hoping to incentivise more biopharmaceutical R&D in the country, and why Japan is “the gateway to Asia” in regulatory terms.   International pharmaceutical companies [should]…

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 In conversation at DIA Europe 2024 in Brussels, Lars Bo Nielsen lays out the digital transformation that the Danish Medicines Agency has undergone over the past three years and how AI can best be integrated into the work of national regulatory bodies.   What does AI really mean? How can…