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In September 2022, the State Medical Products Administration and the Drug Review Center issued a total of 22 regulatory documents and notices in the pharmaceutical field, of which 12 are guiding principles
.
The contents of the NMPA include the revision of drug inserts, the conversion of drug prescriptions, the list of reference preparations, and the announcement of the establishment of the 12th Pharmacopoeia Commission
.
Among them, the Comprehensive Department of the State Food and Drug Administration issued the "Opinions on Reforming and Improving the Review and Approval Administration of Radiopharmaceuticals (Draft for Comments)" to encourage the application of
radiopharmaceuticals for research and development.
CDE has issued a total of 11 guiding principles (draft for comments) and 1 guiding principle (trial) announcement, covering drug immunotoxicity, new drug research and development of ovarian cancer, quality attributes of chewable tablets, clinical trials of compound drugs, and clinical research and development of antitumor antibody conjugate drugs
.
If there is any omission, welcome to add!
On September 30, the Comprehensive Department of the State Food and Drug Administration publicly solicited the "Opinions on Reforming and Improving the Administration of Radiopharmaceutical Review and Approval (Draft for Comments)" Radiopharmaceuticals play a special important role in the diagnosis and treatment of malignant tumors, cardiovascular and cerebrovascular diseases, etc.
, in order to encourage the application of radiopharmaceuticals research and development, the guiding principles put forward a number of incentive measures: priority review and approval of radiopharmaceutical registration applications; Priority will be given to applications for communication and exchange of radiopharmaceuticals; Optimize the working mechanism of registration inspection and registration verification of radioactive drugs
.
Announcement of the State Food and Drug Administration on Revising the Instructions for Cefazolin Injection (No.
82 of 2022) According to the results of the adverse drug reaction assessment, in order to further protect the safety of public drug use, the State Medical Products Administration decided to uniformly revise
the content of the instructions of cefazolin injection (including cefazolin sodium for injection, cefazolin sodium for injection/sodium chloride injection).
82 of 2022)
The Notice of the State Food and Drug Administration on the Release of the Catalogue of Reference Preparations for Generic Drugs (60th Batch) (No.
49 of 2022) was reviewed and determined by the Expert Committee on the Evaluation of the Quality and Efficacy Consistency of Generic Drugs of the State Medical Products Administration, and a total of 94 regulated drugs were successfully selected into the Catalogue of Reference Preparations for Generic Drugs (60th Batch).
49 of 2022)
Announcement of the State Food and Drug Administration on the Establishment of the 12th Pharmacopoeia Commission (No.
80 of 2022) on September 27 The 12th Pharmacopoeia Committee is composed of 454 members, with an executive committee and 29 professional committees, which deliberated and adopted the "Charter of the Pharmacopoeia Committee", "Administrative Measures for Pharmacopoeia Commissioners", "Outline for the Preparation of Chinese Pharmacopoeia (2025 Edition)" and other documents, and the preparation of the 2025 edition of the Chinese Pharmacopoeia was fully launched
.
80 of 2022)
The Notice of the State Food and Drug Administration on the Release of the Catalogue of Reference Preparations for Generic Drugs (Batch 59) (No.
46 of 2022) was reviewed and determined by the Expert Committee for the Evaluation of the Quality and Efficacy Consistency of Generic Drugs of the State Medical Products Administration, and a total of 80 regulated drugs were successfully selected into the Catalogue of Reference Preparations for Generic Drugs (Batch 59).
46 of 2022)
On September 20, the State Food and Drug Administration's announcement on the conversion of Sanpainshu capsules to over-the-counter drugs (No.
79 of 2022) was organized and verified by the State Medical Products Administration, and the relevant drug marketing authorization holders need to file with the provincial drug regulatory department for the revision of the instructions in accordance with the Measures for the Administration of Drug Registration and other relevant provisions before June 15, 2023, and promptly notify relevant medical institutions and pharmaceutical trading enterprises of the revised instructions
。
79 of 2022)
On September 14, the notice of the State Food and Drug Administration on the release of the list of reference preparations for generic drugs (batch 58) (No.
41 of 2022) was reviewed and determined by the Expert Committee for the Evaluation of the Quality and Efficacy Consistency of Generic Drugs of the State Medical Products Administration, and a total of 43 regulated drugs were successfully selected into the reference preparation list of generic drugs (the 58th batch).
41 of 2022)
On September 6, the State Food and Drug Administration announced on amending the instructions of hydroxyethyl starch injections (No.
72 of 2022) According to the results of the adverse drug reaction assessment, the State Medical Products Administration decided to make hydroxyethyl starch injections (including hydroxyethyl starch 20 sodium chloride injection, hydroxyethyl starch 40 sodium chloride injection, hypertonic sodium chloride hydroxyethyl starch 40 injection, hydroxyethyl starch 200/0.
5 sodium chloride injection, Hydroxyethyl starch 130/0.
4 sodium chloride injection, hydroxyethyl starch 130/0.
4 electrolyte injection) instructions were uniformly revised
.
72 of 2022)
Notice of the State Food and Drug Administration on the Use of the Electronic Payment of Registration Fees for Drugs and Medical Devices (No.
37 of 2022) The State Food and Drug Administration has launched the electronic payment of registration fees for drugs and medical device products, the applicant can submit an application for registration of drugs and medical device products in the online office hall of the State Medical Products Administration, and the relevant evaluation center will conduct a review, and after confirming that it is correct, the non-tax income collection management system of the Ministry of Finance will send an electronic payment code to the applicant in the form of SMS, and the applicant can pay through the counter, self-service terminals, Online payment, self-service POS card swiping, bank exchange, transfer payment and other methods of payment
.
37 of 2022)
On September 1, the State Food and Drug Administration and the General Administration of Customs announced (No.
71 of 2022) on the addition of Shijiazhuang Air Port as a drug import port, with the approval of the State Council, agreed to add Shijiazhuang Air Port as a drug import port
.
In addition to the drugs stipulated in Article 10 of the Measures for the Administration of Drug Import (hereinafter referred to as the "Measures"), other imported Chinese medicines (excluding Chinese herbal medicines) and chemicals (including narcotic drugs and psychotropic substances) can be imported through Shijiazhuang Air Port, and Hebei Provincial Institute of Drug and Medical Device Inspection and Research began to undertake the drug port inspection work
of Shijiazhuang Air Port.
71 of 2022)
Center for Drug Evaluation of the State Medical Products Administration
Center for Drug Evaluation of the State Medical Products Administration On September 30, the notice on the public solicitation of opinions on the "Technical Guidelines for Non-clinical Research on Drug Immunotoxicity (Draft for Comments)" has emerged with the emergence of a large number of applications for the research and development of immunorelated therapeutic drugs, and the safety of drugs on the immune system has become a high-profile issue
.
At present, there are no comprehensive guidelines
for the immunotoxicity of chemical drugs and biological products in China.
The purpose of this guideline is to provide general technical guidance and reference
for the evaluation strategies of non-clinical studies of drug immunotoxicity and the trial methods involved.
On September 28, the Drug Review Center of the State Food and Drug Administration issued the "Technical Guidelines for Drug Clinical Dependence Research (Trial)" (No.
35 of 2022) that drug clinical dependence research is an important research content before the market of new drugs with potential abuse risks, and there is no special technical requirement for standardized management
of such studies in China.
Drug dependence assessment can be used to judge the degree of drug dependence and use risk, guide the writing of instructions, and decide on post-market risk monitoring requirements and management standards for drugs (such as listing in the list of narcotic drugs or psychotropic substances).
35 of 2022)
On September 27, on the public solicitation of opinions on the "Technical Guidelines for the Research of New Drugs of Compound Preparations of Traditional Chinese Medicines Based on Human Experience (Draft for Comments)", the notice that human experience is an evidence system for the registration and review of traditional Chinese medicines combining the theory of traditional Chinese medicine, human experience and clinical trials, in order to accelerate the establishment and improvement of the technical evaluation system that meets the characteristics of traditional Chinese medicines and promote the research and development and registration of new drugs of compound preparations of traditional Chinese medicines based on human experience, the Drug Review Center drafted the "Technical Guidelines for the Research of New Drugs of Compound Preparations of Traditional Chinese Medicines Based on Human Experience"
。
Notice on Public Solicitation of Opinions on the Technical Guidelines for the Preparation and Research of Drugs for Clinical Trials of New Chinese Medicines (Draft for Comments) Research on the preparation and quality control of drugs for clinical trials of new Chinese medicines is the basis for carrying out clinical trials and evaluation of new Chinese medicines, which is related to the quality of clinical trials and affects the objectivity and accuracy
of the safety and efficacy evaluation of experimental drugs.
The purpose of these guidelines is to provide technical guidance for the preparation, quality control and other related research of new Chinese medicine drugs for clinical trials, so as to ensure the quality of clinical trial drugs and meet the needs of
clinical trials.
On September 26, the notice on the public solicitation of opinions on the "Technical Guidelines for the Clinical Development of New Drugs for the Treatment of Ovarian Cancer (Draft for Comments)" With the basic research penetrating into the research and development of new drugs, the existing guiding principles cannot cover and specifically target the consideration of clinical trial design for ovarian cancer, the guiding principles aim to elaborate the general design and review considerations of the current clinical trials of new drugs for ovarian cancer, hoping to provide reference for antitumor drug developers in the design and endpoint selection of ovarian cancer clinical trials, improve the efficiency of research and development, and benefit patients as soon as possible
。
Notice on Public Solicitation of Opinions on the Technical Guidelines for the Study of Quality Attributes of Chewable Tablets (Chemicals) (Draft for Comments) For chewable tablets, if the quality attributes are not fully studied and controlled during development, especially key quality attributes such as hardness, disintegration time and dissolution, adverse events
can easily occur in clinical use 。 This guideline was drafted to propose the key quality attributes that should be considered when developing chewable drugs, and to comprehensively study and control them, so as to avoid or reduce adverse events in clinical use, improve patient acceptability, and ensure the safety, efficacy and quality controllability of
drugs.
On September 19, the notice on the "Guidelines for Quantitative Methodology for Extrapolating Adult Drug Data to the Pediatric Population (Draft for Comments)" is one of the strategies and methods of pediatric drug research and development on the basis of
following a good research design, minimizing the number and research steps of the pediatric subject population, and optimizing the drug development process of the pediatric population 。 Extrapolation in these guidelines is a way to provide evidence of the safety and efficacy of a drug in a paediatric population, provided that the course of disease and the expected treatment response of the drug are sufficiently similar
in the pediatric target population and the reference population (adults or other paediatric population).
Notice on September 15 on the public solicitation of opinions on the "Technical Guidelines for Clinical R&D of Antitumor Antibody Conjugate Drugs" With the continuous expansion of ADC drug targets and indications, ADC drugs are leading a new era
of targeted therapy.
At the same time, there are many challenges in clinical development of ADC drugs, including the complexity of pharmacokinetics, insufficient tumor targeting and payload release, and drug resistance
.
The purpose of these guidelines is to provide recommendations
on issues of concern in the clinical development of ADC-class anti-tumor drugs.
The continuous manufacturing process described in the September 9 notice on the public solicitation of opinions on the Technical Guidelines for the Continuous Manufacturing of Chemical Oral Solid Preparations (Draft for Comments) is generally applicable to integrated processes
consisting of two or more solid unit operations directly connected.
The guiding principles clarify the basic considerations for the continuous manufacturing of oral solid dosage of chemical drugs, provide guidance for the research and evaluation of continuous manufacturing technology of oral solid dosage of chemical drugs, and are applicable to the continuous manufacturing
of oral solid preparations of chemical drugs.
On September 8, the notice on the public solicitation of implementation suggestions and Chinese version of the ICH "Q3D(R2): Elemental Impurity Guiding Principles" In order to promote the smooth implementation of the newly revised ICH Guiding Principles in China, Chinese Medicine Prudential formulated the implementation recommendations of "Q3D(R2): Elemental Impurity Guiding Principles" and organized the translation of Chinese versions
.
The Q3D (R2) implementation proposal and the Chinese version are now solicited for public comment for a period of one month
.
On September 7, the notice on the public solicitation of opinions on the "Technical Guidelines for Clinical Trials of Compound Drugs (Draft for Comments)" refers to drugs
containing two or more known active ingredients.
Combination drugs should have significant clinical advantages
over monotherapy.
The guidelines are intended to provide technical advice for the development of clinical trials of new combination drugs, primarily to chemicals, and their general principles also apply to therapeutic biologics
.
This guideline
can also be used for drug development that breaks down into two or more active ingredients in vivo.
On September 5, the notice on the public solicitation of opinions on the "Technical Guidelines for the Prevention of Abuse of Opioid Oral Solid Drugs (Draft for Comments)" is an important part of drugs to relieve moderate to severe pain, in order to encourage applicants to develop oral solid opioid drugs with anti-abuse characteristics and unify the technical review scale, the Drug Review Center organized the drafting of the "Technical Guidelines for the Prevention of Abuse Pharmacy Research of Opioid Oral Solid Drugs (Draft for Comments)", Oral solid opioids for opioids
that use physical / chemical barriers, agonist/antagonist combinations, and aversion anti-abuse technologies alone or in combination.
Reference sources:
Reference Source: Reference Source:[1] CDE and NPMA official websites
[1] CDE and NPMA official websites
