European Medicines Agency (EMA) – The SME Register

Blog41_photoIncentives for micro, small and medium-sized enterprises (SMEs)

Micro, small and medium-sized enterprises (SMEs) play a vital part in the European Healthcare Industry. They are an excellent source of entrepreneurial skills, innovation and employment. Within the European Union, approximately 23 million SMEs provide 75 million jobs across all industries.

Biosimilars – A naming and labelling challenge

Blog 33 - Biosimilars-1 One of the challenges posed to regulators will be the naming requirements for biosimilars. In order for physicians to select the most appropriate biosimilar medicinal product and also for pharmacovigilance purposes, the question has been asked as to what proprietary and/or non-proprietary name should be permitted for use on biosimilar products.

The FDA’s Regulatory Approach to Ebola Therapeutics

Ebola PicIn August 2014, an Emergency Committee meeting, under the International Health Regulations (2005) regarding the ‘2014 Ebola Virus Disease (EVD) outbreak in West Africa’ was held, with WHO later releasing a statement saying that this epidemic had reached the status of Public Health Emergency of International Concern.

CVMP Referrals Procedure

Resolving issues in relation to public health or community interest

Blog 21 - image vetThe Committee for Medicinal Products for Veterinary Use (CVMP) is responsible for preparing opinions on behalf of the European Medicines Agency (EMA) for any issues or questions regarding veterinary medicines. The CVMP referral procedure is used to resolve any issues that may be raised in relation to a veterinary product’s impact on public health or in cases where community interest is called into question.

A referral can be initiated for a number of reasons, as outlined below, under EU pharmaceutical legislation for veterinary medicines (Directive 2001/82/EC, as amended):
Most Common referrals:

Article 33: Mutual-recognition procedure (MRP) and decentralised procedure (DCP) referral
Article 34: Divergent decision referral
Article 35: Community interest referral

The Battle against Falsified Medicines

EU legislation to combat an increasingly significant problem

Regulatory Affairs - Falsified MedicinesThe most commonly used definition for Falsified Medicines, describes them as deliberately and fraudulently mislabelled medicines with respect to identity and/or source. Falsified medicines do not meet the legal prerequisite quality or safety standards, and subsequently put at risk the health of millions of patients who take for granted safe and effective prescription drugs.

Pharmaceutical falsification of medicines is a lucrative and sophisticated business, and it is gradually becoming a significant global problem. The success of the business can be attributed to increased commercial use of the internet. Rogue internet drug websites are the most frequent way that people purchase falsified drugs. These websites bypass the regulatory safeguards that store-based pharmacies must follow, for example the need for a prescription. These websites also appeal to the customers as they offer cheaper medications, and there is also a sense of anonymity when making a purchase online.