Tagged with P

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval Each product category has its own data requirements, foreseen in specific regulations of ANVISA (which…

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…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Which are the main actors involved in public procurement and tendering? As mentioned in Chapter 2, Question 7, each entity of public administration is able to carry out public procurement and tendering in order…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. Please describe the main cost containment policies in place in your country and their fundamental principles a. Pricing and impact of generic/biosimilar approval Generic drugs must have their PF 35% cheaper than the corresponding…

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…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What is the definition of an orphan drug in your country? There is no specific definition for orphan drug in Brazilian current rules. However, we understand that it corresponds with the definition of rare…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil.  1. What is the definition of a vaccine in your country? As per ANVISA Resolution RDC 55/2010, vaccines are immunobiological drugs which contain one or more substances (antigens) that, when injected into an individual, stimulate…

Portugal Diabetes is a rising threat to the Portuguese people, the country’s healthcare system, and its economy. Portugal’s National Diabetes Observatory observed that 1.1 million Portuguese people between the ages of 20 and 79.5 (out of a total population of just 10.3 million) were living with diabetes in 2021.   This…

Global Drawing inspiration from Quentin Tarantino’s directorial breakthrough in the early 1990s, Blue Spoon Consulting’s John Singer explores the pharma sector’s urgent need for a strategic overhaul to ensure success and sustain growth amidst looming patent expirations.   Lex is the flagship investment column of the Financial Times. Its commentaries, currently written…

China No longer a fledgling biotech, oncology-focused BeiGene, originally created in China in 2010 with the idea of carrying out world-class research there, has since expanded its global reach and garnered approvals for its therapies Brukinsa and Tevimbra. The company is on a growth trajectory with product sales reaching USD 2.2…

USA The Pharmaceutical Research and Manufacturers of America (PhRMA) has had a board reshake, naming Gilead Sciences Chairman and CEO Daniel O’Day as its new chair. The reorganisation comes after the industry group’s failed efforts to block the Inflation Reduction Act (IRA) and the departure of several high-profile members.   Gilead…

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…