10 new points in registration of drugs and medicinal ingredients according to Circular 08/2022/TT-BYT

On September 5, 2022, Circular 08/2022/TT-BYT was issued by the Ministry of Health regulating registration for circulation of drugs and medicinal ingredients. Thus, with this circular, a series of administrative procedures in the field of registration of drugs and medicinal ingredients have been innovated and simplified compared to the old regulations (Circular 32/2018/TT-BYT). Join Medgate to learn about 10 new points in drug circulation registration in Circular 08/2022/TT-BYT through the following article.

Deputy Minister of Health Do Xuan Tuyen signed and issued Circular 08/2022/TT-BYT on regulations for registration of circulation of drugs and medicinal ingredients and this circular replaces Circular 32/2018/TT-BYT issued on November 12, 2018.

In Circular 08/2018/TT-BYT, administrative procedures in the field of registration for circulation of drugs, medicinal ingredients, dossiers for extension of circulation registration certificates, dossiers for changing circulation registration certificates, … has been simplified compared to the old regulations with 10 specific contents as follows:

Simplify procedures for registration of circulation of drugs and medicinal ingredients

First, regulations apply information technology to all procedures for registration of circulation of drugs and medicinal ingredients: from application submission, appraisal to returning results.

Second, administrative procedures are simplified, to enhance harmony with regulations and principles of countries in the region and around the world, especially regulations related to legal documents. Important as the Certificate of Pharmaceutical Products (CPP) is the removal of the concept of reference management agency according to the recommendations of the EU and foreign pharmaceutical associations and is amended to the concept of Pharmaceutical Management Agency. Europe (EMA) and the SRA, which follows the World Health Organization (WHO) classification.

Circular 08 also stipulates that pharmaceutical product certificates must have sufficient content according to the form of the World Health Organization published on the website http://www.who.int.

At the same time, in this circular, there is no requirement to have 2 CPPs, but only 1 CPP from the SRA country to increase access to drugs, especially in the case of new drugs and drugs that meet special treatment needs.

Along with that, to ensure access to drugs for people and avoid prolonging the time for granting registration certificates for circulation of drugs and medicinal ingredients, this circular does not require 100% authentication of records but only stipulates Authentication in doubtful cases requires authenticating documents before being licensed.

Third, in order to create favorable conditions for businesses, the new circular has removed the form of authorization letter, only requiring an authorization letter to have a basis for consideration, and does not require authentication of the authorizing person’s signature. and the Ministry of Health identifies this document as an internal document of the enterprise.

The registration company is only allowed to amend and supplement no more than 3 times for documents related to the circulation registration certificate of drugs and medicinal ingredients.

Fourth, to control drugs during the process of granting marketing authorization (MA) and avoid issuing too many marketing registration certificates for the same drug, causing obstacles to drug management, the Ministry of Health has It is clearly stipulated in Circular 08/2022/TT-BYT that only 2 circulation registration certificates are issued for drugs from the same manufacturing facility with the same active ingredient or medicinal ingredient, dosage form, route of administration, and dosage. quantity or concentration for a dosage unit, one marketing registration with the trade name and one marketing registration with the international generic name.

This Circular also specifies that this regulation does not apply to drugs produced for export or processed drugs.

Fifth, to harmonize with regulations in the ASEAN region, this circular stipulates that minor change documents only require notification (11 minor change contents) and do not need to be appraised but only need to be submitted. Register changes and be approved by state management agencies.

According to general regulations, the nature of these changes is only to notify the Pharmaceutical Management Agency before implementation and this change does not change the safety or effectiveness of the drug, so the establishment is allowed to Made right from the time of submitting the application, minor changes only require notification and take full responsibility for the content of changes and additions.

Sixth, according to the current Ministry of Health, the quality of registration dossiers is not standardized, leading to multiple additions, causing difficulties in the appraisal process as well as lengthening time, leading to a backlog of dossiers causing problems. There is a lot of pressure on handling administrative procedures.

Vì vậy, nhằm nâng cao trách nhiệm của cơ sở đăng ký thuốc trong quá trình chuẩn bị hồ sơ, giảm áp lực cho cơ quan quản lý trong việc thẩm định hồ sơ, Thông tư 08/2022/TT-BYT quy định cơ sở đăng ký chỉ được phép sửa đổi, bổ sung không quá 3 lần đối với hồ sơ đăng ký thuốc, nguyên liệu làm thuốc (đăng ký, gia hạn, thay đổi/bổ sung).

Simplified requirements in dossiers requesting extension of registration numbers for circulation of drugs and medicinal ingredients

Seventh, Circular 08/2022/TT-BYT allows application extension without submitting technical documents including test reports, quality standards and testing methods certified by the Institute of Testing. National Vaccine and Medical Biological Products (NICVB) at the time of submitting applications for registration of vaccines, serum containing antibodies, derivatives of human blood and plasma, in order to shorten the waiting time for the above documents and reduce the review period.

Eighth, the circular adds a number of instructions on announcing drugs with proven bioequivalence, announcing original brand-name drugs, reference biological products, announcing the list of domestically produced drugs licensed for circulation by one of the strict drug regulatory agencies (SRA), a list of registered drugs using raw materials (pharmaceutical ingredients) certified to comply with the European Pharmacopoeia (CEP) for production to serve Bidding.

Ninth, regulations on registration number structure to serve management and move towards the goal of applying drug identification codes and regulations on printing traceability codes on drug labels according to international standards.

Tenth, for dossiers to extend registration certificates for circulation of drugs and medicinal ingredients, the new circular has minimized the number of documents to meet the provisions of the Pharmacy Law on documents in the dossier requesting extension. For example, removing the following sections: risk management plan for vaccines, documents proving the origin of raw materials, protection certificates, legal documents of the facility producing pharmaceutical ingredients, excipients, and capsules. , semi-finished medicinal products.

In addition, to speed up the appraisal time of renewal dossiers, this circular clearly stipulates that changes to labels or instructions for use are not made in the renewal dossiers, but changes to labels and instructions for use are not allowed. will be submitted separately according to change and supplement procedures.

Thus, Circular 08/2022/TT-BYT has made new changes compared to the old circular regulations (Circular 32/2018/TT-BYT) to be consistent with regional, world and regional regulations. create favorable conditions in the process of submitting, supplementing, evaluating and approving drug and medicinal ingredient registration dossiers. To learn more about regulations, drug registration processes as well as drug circulation registration services , please contact Medgate via hotline +8498.546.1894 or email: medgatevn@gmail.com