Tagged with Regulation,

Mexico The lowest spender on healthcare as a percentage of GDP in mainland Latin America. A complex and fragmented reimbursement system. Clinical trial approval delays stretching across eight months. One could be forgiven for thinking that attempting to bring innovative medicines to Mexico is a thankless task. Yet, as several country…

Global AstraZeneca’s Anna Litsiou, Carolyn Hynes and Allison Guy, contributing to the September 2024 edition of DIA’s Global Forum magazine, discuss the importance of improving interactions between health technology assessment (HTA) bodies and regulatory authorities.   The need to optimize drug development and facilitate faster access for patients has focused discussions…

Hong Kong Since we last covered Hong Kong in Summer 2023, the territory’s regulatory landscape has taken a major step towards its long-term goal of establishing a full regulatory authority. Having previously required approvals from two separate regulatory authorities in other countries or regions (such as the FDA in the US, the…

China Writing in the July 2024 edition of DIA’s Global Forum magazine Mingcan DU and Fengyun (Vicky) HAN of Johnson & Johnson Global Regulatory Policy and Intelligence look back at the evolution of the use of real-world evidence (RWE) in regulatory decision-making in China, including key use cases and future prospects.…

LatAm For the second consecutive year, DIA Europe hosted a Latin America Town Hall, a panel discussion to foster collaboration and share updates from regulatory activities in Latin America and Europe, and the intersections between them. MSD’s Leonardo Semprun, writing in the May 2024 edition of DIA’s Global Forum magazine, highlights…

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…

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,…

Europe PharmaBoardroom caught up with Niklas Hedberg at DIA Europe 2024 in Brussels to gauge what more needs to be done ahead of the implementation of European HTA regulation in January 2025. Hedberg, who spoke at a host of panels across the event, also gave his take on the EU Pharma…

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…