Tagged with Regulation

France ANSM – Agence Nationale de Sécurité des Médicaments et des Produits de Santé (National Agency for the Safety of Drugs and Health Products)   Key People: Dominique Martin, CEO The National Agency for the Safety of Medicines and Health Products (ANSM) was created by the government in 2011 for strengthening the safety of…

France DSS Direction de la Sécurité (Department of Social Security)   Key People: Director General Mathilde Lignot-Leloup The Directorate of Social Security (DSS) supervises all social security organizations: general scheme funds, basic scheme funds of independent professions other than agricultural, or special schemes funds. It also participates in the supervision of complementary…

France Commission des Affaires Sociales de l’Assemblée Nationale (Commission of Social Affairs, National Assembly)   Key People: Brigitte Bourguignon, Chairwoman Olivier Véran, General Reporter The Social Affairs Committee of the National Assembly is one of the eight standing committees of the French National Assembly. The areas of competence of the Social Affairs Committee are…

Spain According to a survey carried out by the Spanish Foundation for Science and Technology (FECYT) over half of the Spanish population believe Pseudo-therapies to be of real value.   “Public and private establishments that include pseudo-therapies will not be able to call themselves health centres,” Health Minister Maria Luisa Carcedo…

USA Chester “Chip” Davis, Jr, the President and CEO of the Association for Accessible Medicines (AAM) discusses the Creating and Restoring Equal Access to Equivalent Samples Act (CREATES) and how it will improve access to medicines and restore healthy competition to the market.    American taxpayers, along with millions of patients, will benefit…

Spain After a recent course of political shifts, Spain now finds itself with a new minister of health; the third since this past June.  Maria Luisa Carcedo, who was named as the Spanish minister of health by Prime Minister Pedro Sanchez on September 11, has replaced Carmen Monton, who resigned after…

Portugal Lawyer Joana Silveira Botelho provides regular legal assistance to pharmaceutical companies and other entities of the health sector. Here she examines Portugal’s new regulatory framework on cannabis for medicinal purposes.    What will actually change considering that in Portugal (and in the European Union) it is already possible to obtain a marketing…

Malaysia Dr Ramli Zainal, the director at National Pharmaceutical Regulatory Agency (NPRA), expresses the continuous work of NPRA to build a strong regulatory ecosystem in Malaysia and the important role that the Malaysian regulator has in the ASEAN region. He also takes time to explain the upcoming priorities to further establish…

Mexico Cristobal Thompson is the Executive Director at AMIIF (Asociacion Mexicana de Industrias de Investigacion Farmaceutica). The AMIIF represents more than 60 global companies with the aim of contributing to improving health in Mexico through innovative medicine. Here Cristobal discusses Mexico’s regulatory landscape and the countries advances in healthcare.    Mexico has…

Malaysia Datuk Seri Dr. Haji Dzulkefly bin Ahmad, Malaysia’s Minister of Health, sets out his vision and key priorities for healthcare in the country over the course of the new parliamentary session.   My approach is to emphasise primary healthcare by allocating enough resources to empower the public health delivery system…

France Maurice-Pierre Planel, president of the CEPS (Comité économique des produits de santé), details how the French government is unique in the way that they engage in drug pricing and comments on how the transformation of the French healthcare system will impact the CEPS’s role in price negotiation.   You are…

Spain One of the unique aspects of the system is the fragmentation linked to the country’s 17 autonomous regions The Spanish healthcare system performance is ranked as 7th in the world by the World Health Organization (WHO), beating countries such as Japan, the Netherlands, United Kingdom, and the United States. Additionally,…