Tagged with Regulator

Sweden In a market where revolutionary treatments and new technologies threaten to introduce structural changes, the need for national authorities and regulators to adapt and catch up with the pace of the industry is of uttermost importance. Dr Catarina Andersson Forsman, director general of the Swedish Medical Products Agency (MPA), shares…

Medical Cannabis Thailand has recently gained a new status as the first Asian country to legalise medical cannabis for medical treatment and research. In a sweeping move, the Thai parliament voted unanimously in favor of its legalisation in November 2018, with the bill then signed into law in early 2019.    Starting…

Spain María Jesús Lamas, director and César Hernández García, head of medicines for human use at the Spanish Agency of Medicine and Health Products (AEMPS), discuss the challenges impacting the evaluation and analysis of products today. Furthermore, they give insights into why Spain is a leading global clinical trials destination and…

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…

Regulation Dominique Martin, CEO of the ANSM (Agence Nationale de Sécurité du Médicament et des Produits de Santé) provides a fascinating insight into the French process of authorizing drugs and medical products, his commitment to increased transparency and increased efficiency, and the opportunity for France to take the lead in European…

Cyprus Healthcare and life science industry advisory services head at KPMG Cyprus, Iacovos Ghalanos, discusses the challenge of implementing the National Health Insurance Scheme, pricing pressures and how their innovative services help companies manage this crucial trend. Ghalanos also touches on the need for greater collaboration between the public and private…

Algeria Reform is under way in Algeria, and professor Mohamed L’Hadj presents the main themes of hospital reform encompassing the roll out of homecare, international collaboration and better training for better outcomes.   What main objectives and priorities are you pursuing today? Our objectives are geared towards our ambition to provide…

Algeria President of the Health Commission at the Algerian Senate, Louisa Chachoua explores recent changes in Algeria’s healthcare sector, the potential of the new drug agency, and Algeria’s capacity to become a flagship health system for the region. A lot of things have changed since our last encounter, there is a…

Turkey Dr. Hakkı Gürsöz, president of the Turkish Medicines and Medical Devices Agency (TiTCK), provides insights into recent localization and pricing policies and delivers strong messages to both domestic and foreign companies operating in Turkey while underlining TiTCK’s ambitions to work hand-in-hand with the industry, the world’s most respected regulatory authorities…

Brexit The European Medicines Agency has cut Britain out of its contracts 7 months ahead of Brexit. “You might have been working on a cancer drug for decades and built up so much expertise that you are the absolute specialist in your field and now have to transfer all your knowledge…

Hong Kong Professor Justin Wu, chief operating officer of the Chinese University of Hong Kong (CUHK) Medical Center, shares his professional background and interest in gastroenterology, his insights into the research and commercialization environment in Hong Kong, and his hope for government, industry and academia to work together to propel Hong Kong…

Regulatory This week Novartis received approval from the European Commission (EC) for Kymriah, their chimeric antigen receptor T cell (CAR-T) therapy for young people under 25 with cancer of the blood. Leading the way in innovative cancer cures with an unrivalled portfolio of over 20 approved oncology medicines, Novartis is the only company in the…