Tagged with Regulator

India Dr Santosh Indraksha serves as Deputy Drugs Controller (India) for the Central Drugs Standard Control Organisation (CDSCO) under the Indian Ministry of Health and Family Welfare. As a representative of India’s main regulatory body for pharmaceuticals, tasked with overseeing the organisation’s international cell, Dr Indraksha outlines the key upgrades in…

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…

Switzerland For the Swiss Agency for Therapeutic Products (Swissmedic), one of the world’s leading regulatory authorities, 2023 was an important year. Not only did the agency gain recognition from the World Health Organisation (WHO), Swissmedic also saw a Good Manufacturing Practice (GMP) agreement between Switzerland and the US FDA come into…

India The State of Gujarat is one of India’s most culturally diverse, the birthplace of ‘Father of the Nation’ Mahatma Gandhi, and the only place in the world where Asiatic lions can be found in their natural habitat. It is also an economic powerhouse, with key Gujarati industries including dairy, cement,…

USA The US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) approved no less than 55 new drugs in 2023, a number surpassing that of 2022 by almost 50 percent. While 28 rare disease treatments and five novel gene therapies got the green light, the agency also…

Japan Toshi Tominaga of Keio University Hospital, writing in the January 2023 edition of the DIA Global Forum magazine, outlines some recent updates to Japanese drug registration legislation, including how domestically generated academic clinical data can be utilised.   Japan’s current regulatory framework for investigator-initiated trials (IITs) of drug candidates seems…

Brazil Brazil’s ANVISA is commonly recognised as LatAm’s leading national medicines regulator and is defined by the Pan American Health Organization (PAHO) as a National Regulatory Authority of Regional Reference (NRAr) for medicines and vaccines. As part of our Transformative 2023: Regional Pharma Trends report, PharmaBoardroom’s Patrick Burton explores some of the key recent…