Pre-clinical and clinical study reports are the documents, which should on the Registration Dossier for the medicinal product when applying for Marketing Authorization.
Volume and type of pre-clinical and clinical study sufficient for the registration of a medicinal product in Russia depend on the type of medicinal product (generic or original) and on the pharmaceutical form and dosage in which it will be registered.
Categories of medicinal products which do not require clinical studies conducted in Russia for their state registration:
- If the pharmaceutical planned for the registration is a generic drug and its reference drug has been registered and has been used in Russia for over 20 years.
- If a multicentre study involving Russia has been conducted.
- If the preparation is a water solution of a generic drug with the same composition as that of the reference medical product, intended for parenteral (hypodermic, intramuscular, intravenous, intraocular, intracavitary, intra-articulate or intracoronary) administration.
- If the preparation is a solution of a generic drug with the same composition as that of the reference pharmaceutical, intended for peroral administration.
- If the preparation is a generic, with the same composition as that of the reference pharmaceutical, and is manufactured in the form of powder or liophilisate for the preparation of solutions.
- Medicinal gases.
- If the pharmaceutical is a generic ear or eye medicine, with the same composition as that of the reference preparation, manufactured in the form of water solution.
- If the pharmaceutical is a generic topical formulation, with the same composition as that of the reference preparation in the form of water solution.
- If the pharmaceutical is a generic drug, with the same composition as that of the reference pharmaceutical, and is a water solution administered in the form of inhalations via nebulizer or as a nasal spray administered via similar devices.
For the above medicinal products, instead of report on their own pre-clinical and clinical study it is possible to present in the registration dossier a literature review of available data on the use and research of the reference (original) medicinal product.
Pre-clinical study of medicinal products (pre-clinical researches, pre-clinical studies, nonclinical studies, pre-clinical development): a phase in the research which is conducted prior to clinical study with the purpose of eliminating unfavorable effects when using the product for humans.
At this phase there us a significant attrition of candidate products as a result of major In Vitro and In Vivo tests, which make it possible to obtain preliminary information on toxicity, effectiveness, pharmacological properties, pharmacokinetics and metabolism of the product under study. This study phase of medicinal product development is labor and money consuming and very important.
Clinical study of medicinal products is a phase of medicinal product research involving patients and healthy volunteers. Clinical trials include testing a new or existing medicinal product and/or medicinal device in order to determine if it is effective and safe for humans in treating a specific disease/condition. Development of new medicinal products results in treatment or prevention of diseases/conditions and improvement of patients’ quality of life.
Clinical tests establish the following:
- Safety and tolerability of medicine;
- Effectiveness and dosing schedule;
- Possible side effects.
Pre-clinical and clinical studies for our clients are conducted by our partner, OOO LABMGMU. Detailed information on procedure and terms may be received on website http://labmgmu.ru