What is a Pharmacopoeia and why is it needed?
Recently, the Order of the Ministry of Health of the Russian Federation No. 685p of October 21, 2022 “On Amendments to Certain Orders of the Ministry of Health of the Russian Federation on the Approval of General Pharmacopoeia Articles and Pharmacopoeia Articles” was published, according to which the transition period to the State Pharmacopoeia (SP) XIV is extended until January 01, 2026. (Previously the deadline was January 01, 2023). What does this mean for the pharmaceutical industry?
Pharmacopoeia (from ancient Greek φαρμακον “medicine” + ποιη “I make, produce”) is a collection of regulatory documents (monographs) that regulate the requirements for the quality of medicines. Monographs are divided into general and private. General monographs contain descriptions of methods for the analysis of medicinal products, data on the reagents and indicators used in this case. Special monographs – standards of medicines, contain lists of indicators and methods for quality control of medicines and descriptions of medicines, as well as excipients and raw materials for their production.
Many countries develop their own Pharmacopoeias. Most often, pharmaceutical industry employees refer to the pharmacopoeias of the EU, US, Japan and the UK. In addition, there is the International Pharmacopoeia, which is published by WHO. Since 1778, the Pharmacopoeia has also been published in Russia. The latest state pharmacopoeia (SPh) XIII contains 229 general and 179 special monographs.
In connection with the entry into force of the registration procedure for medicines according to the requirements of the EAEU, it also became necessary to create a Pharmacopoeia that would be recognized by all member states of the Union. So, in 2020, the first volume of the EAEU Pharmacopoeia was approved. However, many monographs have not yet been included in the EAEU Pharmacopoeia, which creates certain difficulties during registration.
How is the registration procedure and the Pharmacopoeia related?
The fact is that when developing a normative document, the text must refer to one or another standard, according to which this or that analysis is carried out. For example:
It should be noted that in this case, this ND already needs to be improved, even if the drug is still registered according to the national system, and not according to the requirements of the EAEU, since SPh XI is not an up-to-date version.
Thus, coming back to the new Order, applicants can wait with updating the dossier to bring it in line with SPh XIV a little longer.
- Order of the Ministry of Health of the Russian Federation No. 685p dated October 21, 2022 “On Amendments to Certain Orders of the Ministry of Health of the Russian Federation on Approval of General Pharmacopoeial Articles and Pharmacopoeial Articles”
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