WHO Prequalification Programme. Opportunities for Drug Product and API manufacturers.
The WHO Prequalification Team provides advice to UN agencies and international medicine procurers on the quality, safety and efficacy of purchased medicines. In most cases, eligibility for procurement requires the medicine to be either approved by a Stringent Regulatory agency or prequalified by the WHO Prequalification Team.
This presentation will provide an introduction to the medicine and API prequalification programme including: who may apply, what are the requirements and procedures. The possibility for arranging technical assistance to potential manufacturers who wish to participate will be outlined.
Finally, the presentation will also introduce the WHO collaborative procedure. This is a procedure introduced to significantly reduce national registration times for prequalified products, allowing sales of the medicine to the local market quickly. The procedure requests a decision from the national medicines authority within 90 days. Nearly 30 countries are now participating in this scheme.
About Dr Anthony Fake
Dr Antony Fake has worked with the WHO Prequalification Team since 2010. He is the focal point for API-related assessments within the Prequalification Team – Medicines Assessment (WHO), based in Geneva. This includes oversight of the API Prequalification procedure and API assessment in support of Finished Pharmaceutical Products seeking Prequalification.
He is currently Co-chair of the International Generics Drugs Regulatory Programme, Quality Working Group and recently participated in the ICH Q11 Q&A working group.
Before joining WHO he was Team Leader Prescription Medicines at the New Zealand Medicine Regulator (Medsafe) in 2000. He is a Chemist by training.
- Regulatory Control of Finished Pharmaceutical Product in Malaysia
- Registration of Finished Pharmaceutical Product in Malaysia
Control of Drugs and Cosmetics Regulations 1984 promulgated under the Sale of Drugs Act 1952 provide mandatory product registration and licensing of premises that deal with the said product. The Drug Control Authority has been established for the purposes of these Regulations, where the National Pharmaceutical Regulatory Agency (NPRA) acts as its secretariat. These presentations will provide you an overview of the regulating body, the legal basis and regulatory process for finished pharmaceutical product and provide an insight pertaining to finished pharmaceutical product registration in Malaysia.
About Yee Lai Jiuan
Yee Lai Jiuan is a registered pharmacist in the public service in Malaysia. She holds a Master's Degree in Criminal Justice. She joined the Regulatory Coordination Section under the Centre of Product Registration, NPRA in 2010. She is involved in matters pertaining to Drug Control Authority meeting and regulatory policy in NPRA.
- Part A: Understanding the opportunity: Markets, regulation and dynamics of the Middle East and North Africa region
- Part B: Rising to the opportunity: Strategic approaches to successfully entering the MENA markets
About 55east Consulting
The Middle East and North Africa region offers the most dynamic health care markets in the world: in fact, this region and Sub-Saharan Africa will be the last region to offer double-digit growth to pharmaceutical companies. Growing populations, rising middle classes, increased government spending and some of the highest rates of chronic diseases globally will drive continued demand. However, the MENA expansion decisions often suffer from the perceived political and security risks, a lack of data and unclarity about regulatory and commercial requirements. The lecture will provide an overview of the region, its most important markets, key regulations in approval and reimbursement of drugs and practical approaches to entering and operating successfully in MENA.
About Claudia Palme
Claudia Palme is a partner at consulting firm 55east and senior advisor in the global Life Sciences and Health Care industry, based in Dubai, UAE. Her engagements focus on new business models, emerging markets’ expansion, growth and restructuring strategy and investment advisory. Claudia has spent 20 years in senior management in the pharmaceutical industry at Amgen and Novartis and in consulting at The Boston Consulting Group and booz & company across Europe, the Middle East, Africa and Latin America. Before setting up 55east in 2014, she led Strategic Planning and Operations for the Middle East and Africa region at Amgen.
Claudia holds a Master’s Degree in Public Administration from Harvard and a Master’s in Economics from LMU Munich. She has co-published a book on policy reforms in Germany and papers on German health care reform.