July 24, 2022
Smart regulation
It's not a secret that registration of a medicinal product is a long and laborious process. In this regard, in many countries (regions) the so-called "smart" regulation is actively implemented, which allows optimize regulatory work and facilitate the release of the drug to the market and, as a result, deliver the drug to the patient in a short time.
Smart regulation is effective work of regulators aimed at eliminating duplication of redundant procedures, the use of risk-based models, focused on the use of limited resources to solve the most pressing health problems and get the maximum results to ensure that patients quickly access innovative and affordable treatment.
In the EU, the concept of smart regulation began to be discussed in 2010, not only in relation to the healthcare sector. Then the Commission of the European Union identified three main characteristics of smart regulation:
- it concerns the whole policy cycle - from the design of a piece of legislation, to implementation, enforcement, evaluation and revision.
- it must be a shared responsibility of the European institutions and of Member States; and
- the views of those most affected by regulation have a key role to play in smart regulation.
One of the areas of smart regulation is regulatory reliance. This is an action whereby a regulator in one jurisdiction takes into account and gives significant weight to the assessments made by another regulator or authorized agency, or any other official information, when making its own decision. The trusting authority remains independent and responsible for its decisions, even if it relies on decisions and information from other authorities. Сonsequently, reliance is not equal to recognition.
Currently, the reliance model is widely used in the world in the evaluation of clinical trial data, inspections, examination and registration of drugs.
- Materials of the SCIENTIFIC-PRACTICAL CONFERENCE “MODERN APPROACHES TO THE EXAMINATION AND REGISTRATION OF MEDICINES” REGLEK — 2022
