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Mexico The latest stories from Mexican pharma and healthcare, including Sanfer’s purchase of Colombia-based manufacturer Vitalis; Organon Mexico’s new business; the FDA’s warning to Glicerinas Industriales, and a look at the issues, including health, the new Mexican president will have to face.   Mexico’s Health Ministry issues measles alert (Mexico News) Mexico’s…

China In recent years, global pharma’s Business Development (BD) operations in Asia have evolved from primarily managing global agreements locally to engaging in more complex tasks like contract negotiation and due diligence. Servier’s Asia BD Head Cynthia Xin Wang explains how this shift reflects changing market dynamics and the growing importance…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal.  1. What are the pricing models, processes and principles for originator drugs? Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal.  1. Has an essential or priority drug list been published in your country? (If so provide the link) Portuguese health authorities have not approved an “essential medicines list”. However, there’s a list in force in…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. What are the pricing models, processes and principles for originator drugs? An original drug is defined as a drug approved by Swissmedic as the first drug with a specific active ingredient, including all dosage…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Has an essential or priority drug list been published in your country? (If so provide the link) Yes, Switzerland publishes such a list in the annex to the ordinance on the Essential Human Medicines…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. What are the pricing principles and processes in your country? As mentioned above, there are two main markets for medicines in Denmark: the primary healthcare sector (prescription medicines) and the secondary sector (hospitals).…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Has an essential or priority drug list been published in your country? (If so provide the link) The guideline process of the Danish Medicines Council results in recommendations with prioritized list of medicines…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. What are the pricing models, processes and principles for originator drugs? The main enactment setting out the pricing models and approval procedures for medicines is Ministry of Health’s Order no. 368/2017 approving the Norms…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What are the pricing models, processes and principles for originator drugs? To set the price of originator drugs, CMED uses Health Technology Assessment (“HTA”) to evaluate whether a drug provides an additional therapeutic benefit…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Romania.  1. Has an essential or priority drug list been published in your country? (If so provide the link) The list of essential medicinal products was approved by means of a Ministry of Health’s order, published…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Has an essential or priority drug list been published in your country? (If so provide the link)   Yes. In Brazil, the National List of Essential Drugs (“RENAME”) provides the selection and standardisation of…