EMA Creates New Working Party to Represent Healthcare Providers in Regulatory Process

The European Medicines Agency (EMA) has announced the formation of a new advisory council known as the Healthcare Professionals' Working Party (HCPWP), which is intended to provide regulators with the perspective of healthcare professionals on the regulation of medicinal products.

The announcement, made on 9 July 2013, notes that regulators had previously relied on healthcare professionals' advice on an informal basis through a working group within its Committee for Medicinal Products for Human use (CHMP).

However, now EMA has "formalized" the group, giving it more of an ability to interact across committees, including the CHMP, the  Pharmacovigilance Risk Assessment Committee (PRAC), the Committee on Herbal Medicinal Products (HMPC), the Committee for Orphan Medicinal Products (COMP), the Paediatric Committee (PDCO) and the Committee for Advanced Therapies (CAT).

"The working party will provide continuous input on the evaluation and safety monitoring of medicines throughout their lifecycle," EMA explained in a statement, adding that the group plans to meet quarterly.

The HCPWP has six principal tasks:

• consult with EMA on the way medicines are used in clinical practice
• work with EMA to improve the benefit-risk assessment of medicines throughout their respective lifecycles
• help EMA to provided clearer and more useful information to other healthcare professionals
• bring the perspectives of the healthcare professional into EMA's regulatory processes
• help bridge information from EMA to their respective professional groups
• act as ambassadors for EMA to other healthcare professionals

The HCPWP will be composed of professionals from at least 18 societies, including those representing AIDS clinians, pharmacologists, diabetes, hospital pharmacists, urology, internists, neurologists, oncologists, cardiologists, endocrinologists, nurses, radiologists, and more.

38 members are currently involved in the group. A similar arrangement is in place with patients and consumers through a Patient's and Consumers' Working Party (PCWP), EMA noted.

EMA Statement

HCPWP Page