Tagged with Regulatory

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…

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 Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The National HTA program is overseen by the Health Technology Assessment Section (HTAS) of the HIBD (see above chapter…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.  1. Please make a general introduction to the public health sector in your country and its organization   The Danish healthcare system The Danish public healthcare system is universal – all registered Danish residents are…

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…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? In Brazil, CONITEC is the main HTA evaluation body, which is responsible for recommending the incorporation of health technologies…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Are there any Managed entry agreements in place in your country? (If so, please list them) The first public and only managed access agreement reported in Brazil was signed between the Ministry of Health…