December 2021 Monthly Newsletter

The development of innovative medicines and technologies has been shown to be key to tackling serious unmet medical need. Many such innovations stem from micro, small, and medium-sized enterprises (SMEs), from academia and from not-for-profit organizations. In fact, across all industries SMEs have been found to be the main fabric of Europe’s economy.

However, cost is often a barrier for these research organizations, including the cost of filing regulatory submissions. To support innovation and help SMEs bring products to the market, the European Medicines Agency offers significant benefits, including fee exemptions and reductions for regulatory submissions and for scientific advice. (See Fee Incentives chart)

French guidelines on good pharmacovigilance practices from the French national agency for medicines and health products safety (ANSM) describe a pharmacovigilance survey as an evaluation or assessment of work regarding the risk of an adverse drug reaction in the context of a potential or valid signal or to provide strengthened monitoring of the risk profile of a drug.

To achieve this, a review of all available pharmacovigilance data must be performed.

In response to a rapid increase in applicants seeking to bring drug-device combination products to market in China, the country’s National Medical Products Administration (NMPA) recently released new draft guidelines. With the demand for innovative products to prevent and treat disease growing, the NMPA prepared the draft guidelines with the objective of clarifying processes for applicants.

A new version of the online payment system from the Italian Medicines Agency (AIFA) has become available, making the system easier to use, including making payments via PagoPA, Italy’s public system for electronic payments to public authorities.

While the pharmaceutical market is typically considered to be exclusively about drugs, food supplements are included as a product category within the broader pharmaceutical sector.

Directive 2002/46/EC defines ‘food supplements’ as foodstuffs designed to “supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form, namely forms such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities.