1. “Regulatory Guillotine” in the pharmaceutical industry: general approaches and implementation specifics

2. Regulatory Guillotine: definition and substantiation
Presidential Address to the Federal Assembly of the Russian Federation dd “Presidential Address to the Federal Assembly”
Action plan (roadmap) for implementation of the Regulatory Guillotine, approved by the Chairman of the Government of the Russian Federation under No. 4714p-P36 dd
deliberate restriction of the monitoring (surveillance) subject by omitting some requirements that were previously mandatory for inspection by authorized bodies, on the basis provided in a dedicated legal act

3. Regulatory Guillotine patterns
Simplified administrative procedures (Vietnam, France, Moldova)
Inventory check and classification of effective regulatory base on the basis of Regulatory Guillotine projects implemented by Jacobs, Cordova & Associates (Croatia, Kyrgizistan)
Justification of regulatory intervention (EU), involving quality regulation to be based on the best available evidence, including research and expert data
Deregulation (UK)

4. Framework of the Federal Law draft “Mandatory requirements”
One-time amendment, cancellation or introduction of new mandatory requirements on January 1, 2021
Prohibition of mandatory requirements, except for those set for statutory purposes
Unified approaches to and procedures of mandatory requirement review, regulated at the legal level

5. Risks of the Regulatory Guillotine
Approach to definition of “mandatory requirements”
Complete deletion of regulations stating mandatory requirements
Restricted approach of developers by cancelling bylaw requirements only
Different detail content of mandatory requirements
Risk as a basis of legal force of a mandatory requirement