Pre-submission scientific counseling is a routine practice in FDA and EMA. Regulatory professionals and pharmaceutical companies meet to coordinate requirements for new drug approval process, postmarketing surveillance strategy and management strategies for other special conditions. Approach to drug registration is quite different in Russia.
According to Federal Law, 61-ФЗ pharmaceutical company can request scientific counseling in Russian Ministry of Health (MoH) before submitting the registration dossier. MoH should contact its own expert bodies to agree on drug approval conditions and get back to the applicant. The pharmaceutical company, therefore, is not allowed to interact with experts directly.
Specialists of Scientific Centre for Expert Evaluation of Medicinal Products (SCEEMP), Russian expert agency attached to MoH, discuss this issue in a recently published article. The absence of direct contact between an expert agency and pharmaceutical company slows the new drug registration procedure down because it increases a probability of errors in study planning and conduct, or even in document design and contents.
SCEEMP specialists explain that main purpose of the current legislation is to prevent conflict of interests between an expert agency and pharmaceutical company, yet, such legislation also prevents new drugs timely approval. In this article, experts also review EMA and FDA experience in pre-submission advice organization. Specialists of these agencies contact pharmaceutical company representatives directly to minimize potential time loss due to post-submission correction of the registration dossier and approved meeting strategies are utilized to minimize the overall submission timelines.
SCEEMP experts conclude that changes in approach to scientific counseling in Russia can accelerate new drug registration process and increase the availability of new drugs as well as increase attractiveness of Russian clinical trial market. Pre-submission counseling procedure will probably change eventually, as this issue has already gotten into the spotlight.