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 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…
Opinion Writing in the March 2024 edition of the DIA Global Forum magazine, experts from Moderna, Cencora PharmaLex, CureVac, and BioNTech review the scientific potential and regulatory challenges, such as the lack of global harmonization, surrounding gene therapy-based medicinal products. Gene therapy medicinal products (GTMPs), which in the European Union (EU)…
Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport) The policy and regulation of drugs (‘medicinal products’), biologicals and medical devices falls under the jurisdiction of the Ministry of Health,…
Pharma Legal Handbook 1. Are there proposals for reform or significant change to the healthcare system? Reform of the Drug Reimbursement System The policy on medicinal products of the Ministry of Health Welfare and Sport is based on three core values: quality, accessibility and affordability. In order to improve the affordability of healthcare,…
LatAm An overview of some of the biggest stories from Latin American pharma and healthcare, including Brazil’s rollout of dengue vaccines following a sharp increase in cases; the Brazilian regulatory agency ANVISA’s strategy to become a WHO-listed authority andAspid Pharma’s agreement with Institute for Research on Obesity of the Tecnológico de…
Brazil Brazil’s ANVISA is commonly recognised as LatAm’s leading national medicines regulator and is defined by the Pan American Health Organization (PAHO) as a National Regulatory Authority of Regional Reference (NRAr) for medicines and vaccines. As part of our Transformative 2023: Regional Pharma Trends report, PharmaBoardroom’s Patrick Burton explores some of the key recent…
Hong Kong Hong Kong provides some of the best and most efficient healthcare in Asia, with Hong Kongers living to over 85 on average (compared to 83 in Singapore and 78 in mainland China), and the World Health Organisation ranks the city among the top 20 healthcare systems globally. However, unlike many…
Americas Writing in the August edition of DIA’s Global Forum magazine, Silvia B. Bendiner of WESSX Inc. and Belkis Romeu call for greater regulatory collaboration between Latin American countries, building on an initiative created by Dr. Rafael Pérez Cristiá at the Cuban Regulatory Authority (CECMED). The need for further regulatory…
Africa Writing in the July 2023 edition of DIA’s Global Forum magazine, Nevena Miletic of Roche and the IFPMA’s Africa Regulatory Network and Ian Hudson from the Bill and Melinda Gates Foundation look back on the progress made towards instituting an African Medicines Agency and the next steps in this important…
UAE With a welter of regulatory upgrades in the UAE and Saudi Arabia in recent years, patients in the Middle East’s leading countries now have wider and faster access to cutting-edge biopharmaceutical innovation than ever before. Here, four leading lights in the region’s pharmaceutical industry highlight some of the most important…
Europe Writing in the June 2023 edition of DIA’s Global Forum magazine, Angelika Joos of MSD and Susanne Ausborn Roche consider some of the key takeaways from a workshop on regulatory reliance at DIA Europe 2023 which brought together international representatives from both industry and regulatory bodies. Reliance* is considered the…
See our Cookie Privacy Policy Here