Tagged with Pharma

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…

India Shailesh Siroya explains the rationale behind Bal Pharma’s strategic focus on niche products within the API segment, avoiding the broader, more competitive commodity markets and enabling it to establish a significant global presence. Siroya also outlines how Bal Pharma has evolved from its initial focus on the export market to…

India Multinational life science firms have been present in India for decades. However, they have often eschewed bringing their latest products to a country that has long prioritised affordability above innovation. Now though, as India’s GDP and market value soar and the policy environment shifts towards prioritising the domestic development of…

Portugal After achieving the highest sales figures in the affiliate’s history in 2023, general manager of Teva Pharmaceuticals Portugal Marta Gonzalez Casal outlines the restructuring efforts that have taken place in Portugal to strengthen its commercial operations. She also reviews the company’s shift towards innovation and the challenges of Teva’s hospital…

India Mohal Sarabhai, managing director of Ambalal Sarabhai Enterprises Limited (ASE) on transforming his family’s failing century-old business and creating new companies beneath the ASE Holdings umbrella, including a joint venture with Co-Diagnostics, CoSara Diagnostics, that span areas from diagnostics to APIs. He highlights CoSara Diagnostics’ tuberculosis (TB) and human papillomavirus…

Pharma Legal Handbook An intro to the legal situation for regulatory, pricing and reimbursement of drugs in Croatia. Prepared in association with Danijel Pribanić, a leading global law firm, this is an extract from The Pharma Legal Handbook: Croatia, available to purchase here for GB 119.   1. What are the regulatory authorities…

Pharma Legal Handbook An insight into regulatory, pricing and reimbursement overview in Czech Republic. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.   1. What are the regulatory authorities with…

Pharma Legal Handbook An intro to the legal situation for regulatory, pricing and reimbursement in Slovakian Pharma. Prepared in association with PRK Partners, a leading global law firm, this is an extract from The Pharma Legal Handbook: Slovakia, available to purchase here for GBP 75.   1. What are the regulatory authorities with jurisdiction over…

Pharma Legal Handbook Preclinical & clinical trial requirements in Czech Republic – an overview. Prepared in association with PRK Partners, a leading law firm in Czech Republic, this is an extract from The Pharma Legal Handbook: Czech Republic, available to purchase here for GBP 119.   1. Are clinical trials required to be…