The government has instructed all concerned departments to agree on the decision to waive the mandatory certification of immunobiological medicines. This is stated in the minutes of the meeting held on 20 February, the Deputy head of the government apparatus by Nelly Naigovzina (a copy of the document has).
From the Protocol follows that in the period up to March 15, the Ministry of industry and trade, Ministry of health, Roszdravnadzor and other agencies concerned should agree to the draft government resolution on excluding of the immunobiological preparations from the single list of products subject to mandatory certification.
The representative of Roszdravnadzor reported that the office has developed a project that will make the process of testing drugs is “more transparent”, but the changes did not comment on. The documents, he said, are being coordinated in the Ministry of health. The representative of the Ministry of health declined to comment, the press service of the government office and the Ministry of industry and trade has not responded to the request . But a government source confirmed the meeting at Naigovzina, and a source in the leadership of the Ministry of health reported that the decision to abandon certification of vaccines really worked.
The abolition of certification may follow after in Russia has started the supply of Western drugs.
In the category of immunobiological preparations include vaccines, toxoids, immunoglobulins and other medicinal products that are intended to create specific immunity to infectious diseases.
According to DSM Group, the annual volume of the market of immunobiological products in the retail segment is about 54 billion rubles, and about 55 million packages. The expenditure budget for the purchase of vaccines under National immunisation schedule (NCP) in 2015 amounted to 10.2 billion rubles.
Shortage of vaccines
In January 2016 a big foreign vaccine manufacturers, Sanofi and GlaxoSmithKline (GSK) said that can’t put their preparations to the Russian market from-for problems with their certification. Difficulties with documents in foreign pharmaceutical companies have emerged due to the fact that in November of 2015 Federal service for accreditation (Rosakkreditatsia) after an unscheduled inspection has suspended the license of the INSTITUTION “Scientific centre of medical products” (scemp), subordinated to the Ministry of health. In this body all vaccines Sanofi and GSK have passed mandatory certification.
7 December scemp returned the license, but the Federal accreditation service advised the research center change the certification procedure. Instead of testing the vaccine on an abbreviated scheme, which was carried out in recent years, the research center was asked to conduct complete testing.
Because of problems with certification disappeared from the market including childhood vaccines against whooping cough, diphtheria and tetanus “Pentaxim” (Sanofi) and “Hexa Infanrix” (GSK), as well as vaccine against infections caused by Haemophilus influenzae, “Act Hib” (Sanofi and GSK).
The representatives of GSK, Sanofi and Pfizer (produces the vaccine “Prevenar-13”) reported that it is not yet known about the government’s plans to cancel the certification of vaccines in Russia.
The new standard
The planned withdrawal of certification is not associated directly with emerged on the market deficiency, says a source in the Ministry of health. The fact that from 1 January 2016, foreign pharmaceutical companies are obliged to register new drugs in accordance with Russian requirements. According to the adopted amendments to the law “On circulation of medicines”, from 2016 all foreign pharmaceutical companies who are going to deduce on the Russian market new drugs must register them according to the standard Good Manufacturing Practice for Medicinal Products (GMP). From 2017, this requirement will apply generally to all sold in Russia drugs. Many businesses large Western manufacturers (including those that supply disappeared from sale of foreign vaccines) already meet the GMP standard, so that the additional certification of their products in Russia will not be required, says a source in the Ministry of health.
What is the GMP standard
Standards for safe production of drugs began to be developed in the U.S. in the 1960-ies, the status of international GMP standards received in 1968. GMP regulations include a list of requirements to be met by manufacturers of medicines and other pharmaceutical products. In world practice, the certification of GMP production doing inspection with the state or authorised private companies, says development Director of the company RNC Pharma Nikolay Bespalov.
In Russia responsible for validating suppliers for compliance with the GMP rules assigned to the Ministry of industry and trade. Since January the Ministry has been given the authority to inspect drug factories abroad directly (but by 2017 this inspection is mandatory only for suppliers of those drugs, which have not been supplied in Russia). However, this provision still does not work, wrote Kommersant: Russian Inspectorate abroad there is no legal basis.
Western vaccines, missing in Russia, can be on sale even before the government will approve the waiver of certification. At the meeting of February 20, the Ministry of health and scemp was instructed already from March 5 to ensure the renewal of certification of immunobiological preparations on the custom and factory stock, it follows from the Protocol. Assessment Director of the Association of international pharmaceutical manufacturers Vladimir šípková, we are talking about approximately 1.5 million packs of drugs.
Certification preparation “Pentaxim” will occur not earlier than March 15, 2016, commented on the execution of the order, the representative of the scemp. “The duration of the process of confirming the compliance of the vaccine involves complex biological analysis, the reagents for which the manufacturer of the vaccine provided to the certification body on 29 February,” he explained. The issue of the certificate on the drug “Infanrix Hexa” in connection with the duration of animal testing is planned in the first half of April 2016.
Certification is a useful tool to monitor the quality of production, says the Director of the state budgetary institution research Institute for health organization and medical management of the Department of health of Moscow David Melik-Guseinov. “But if this tool shows failures, as was the case with vaccines, it is better to either set, or canceled altogether,” he said. Now the system of state procurement of vaccines goes through “Natimbi”, it is possible that the organization will be transferred to and options for quality control of vaccines, admits it. The press service of “Natimbi” (“daughter” company “Microgen”, is the only supplier of vaccines for vaccinations that are included in NCP for 2015-2017) not provided comment.
The idea to abandon common certification, but need to debug the inspection of the Ministry of foreign manufacturers, said development Director RNC Pharma Nikolay Bespalov. “If certification is withdrawn, and the GMP Inspectorate will not be able to test sites in Russia again may be a risk of a shortage of drugs,” he warns.
But there are experts who consider the idea of canceling the certification threat. “No simplified arrangements for immunobiological drugs can not be, — says the General Director of the analytical company DSM Group Sergey shuljak. — Every time a property immunobiological molecules need to prove again.” “The control which is performed when certification is required, — agrees the head of a private company “Format quality” (also certifies medical drugs) Mikhail Yaroshenko. — Immunobiological preparations is a special category, they need to be checked carefully. We can’t know for sure that we’re bringing in from abroad!” Shipkov believes that periodic audits of public bodies immunobiological preparations, in circulation will be enough.
Declarations instead of certificates
The certification procedure can be replaced by a Declaration that the option was discussed at the government session on 20 February, says CEO of the Association of Russian pharmaceutical manufacturers Victor Dmitriev, who took part in the meeting.
When certifying the quality of drugs is confirmed by an independent certification body on the basis of tests in the Declaration — by the applicant, explains the difference Yaroshenko. In the first case, the responsibility for product quality and carry manufacturer and the certification body, in the latter case, only the manufacturer. But even in this case, Roszdravnadzor may retain the ability to periodically test the quality of drugs, said Dmitriev.
Now the quality of some medicines confirmed through declarations. But in the corresponding list of products none of immunobiological drug.