Preclinical and Clinical Trial Requirements
All about preclinical and clinical trial requirements in Russia. Prepared in association with Lidings, a leading global law firm, this is an extract from The Pharma Legal Handbook: Russia, available to purchase here for USD 99.
1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval?
According to Cl. 16 Art. 18 of Law on Circulation of Drugs clinical trials shall be concluded locally and shall be subject to prior permit from Minzdrav, clinical trials in respect of orphan drugs may be conducted in other jurisdictions but subject to requirements, provided by good clinical practice.
2. How are clinical trials funded?
Subject to Art. 42 of Law on Circulation of Drugs clinical trials may be funded with budgetary funds, funds of the developer of the drug and other sources.
3. What are the requirements for preclinical and clinical trial protocols? Who must approve the protocols?
Preclinical data shall be collected to justify whether clinical trials can be conducted and are subject to good laboratory practice. The developer of the medical product shall maintain the protocol of such preclinical trials.
Protocols, i.e. plans, for clinical trials, shall be developed by the developer of the drug and filed with Minzdrav among the documents required for the permit to conduct clinical trials. Such permit includes ethical examination. Once the permit is obtained the protocol shall be transferred to the organization which ensures clinical trials to be conducted. When conducting the trials, such organization, that may be the developer, universities or research institutions, may request Minzdrav to approve amendments to the protocol. The final report on clinical trials shall be made by the organization that ensures clinical trials to be conducted and filed with Minzdrav.
Essentially, clinical trials are subject to ethical guidelines, rights and welfare of human beings.
4. What are the requirements for consent by participants in clinical trials?
The participation of patient in clinical trial shall be voluntary and subject to his written informed consent which may be revoked.
5. May participants in clinical trials be compensated?
The participants shall not be compensated but their risk shall be insured. Such insurance is compulsory (for more details please see Question 21 below).
6. How are participants in clinical trials protected and indemnified against any harm that arises as a result of participation in the trial?
The risks of the participants shall be subject to compulsory insurance, as provided by Art. 44 of Law on Circulation of Drugs. The minimum value of compensation in case of occurrence of each type is stated by the law.