China Drug Approvals at Record High for 2020
The following is an overview from Accestra Consulting* of Part 2 of China’s Center for Drug Evaluation (CDE)’s 2020 reporting, including an…
Tagged with Regulator
Regulatory Cooperation & Joint Assessments in ASEAN
Writing in the September edition of DIA’s Global Forum magazine, Rosilawati Ahmad of Malaysia's National Pharmaceutical Regulatory Agency;…
PhIRDA’s Song Ruilin on Strengthening China’s Drug…
Song Ruilin, chairman of the China Pharmaceutical Innovation and Research Development Association (PhIRDA), picks out the key learnings from recent…
CDE’s China Drug Evaluation Report 2020: Part 1
The following is an overview from Accestra Consulting* of Part 1 of China’s Center for Drug Evaluation (CDE)’s 2020 reporting, including data on…
Top 2021 Insights from Global Regulators
Over the past 12 months, PharmaBoardroom has spoken to the heads of several key regulatory bodies across the world. While the approval processes for…
Lars Bo Nielsen – Director General, Danish Medicines Agency
In a wide-ranging interview, incoming director general of the Danish Medicines Agency Lars Bo Nielsen discusses the challenges that personalised…
Tolga Karakan – President, Turkish Medicines and Medical…
TITCK is the regulatory agency in charge of ensuring the safety of medicines, health products, cosmetics, and personal care products in Turkey. Its…
Turkey: A Question of Timing: Negative Declaratory Relief in…
Istanbul’s First Instance IP Court recently dismissed a negative declaratory action (the “Case”) against our client citing the plaintiff’s…
APAC: Self-Medication in the Age of COVID: The Country-Specific…
Writing in the May edition of DIA’s Global Forum magazine, Toshiyoshi Tominaga of the Asia-Pacific Self-Medication Industry (APSMI) looks at the…
Aligning Combination Product Regulations in Asia-Pacific: A…
Writing in the April edition of DIA’s Global Forum magazine, Dhiraj Behl, Janine Jamieson, and Harikesh Kalonia highlight some of the regulatory…
Importance of Reliance to Support Strengthening Latin American…
Writing in the April edition of DIA’s Global Forum magazine, Maria Cristina Mota Pina of Abbvie on behalf of FIFARMA Regulatory & Biologics…
Saudi Arabia: SFDA CEO Sets Out Strategic Priorities
In a recent conversation with PharmaBoardroom, Prof. Hisham Bin Saad Al-Jadhey, CEO of the Saudi Food and Drug Authority (SFDA) outlined the…
