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Regulatory Newsletter

Q1 2022 Regulatory Updates
May. 01, 2022
Q1 2022 Regulatory Updates

WuXi Biologics’ Regulatory Affairs team is honored to provide you with a summary of what we deem as the relevant (i.e., product development and CMC-related) regulatory updates that are either in draft or final status by agency and by topic. We have compiled these updates to support your efforts to stay current in the ever-changing regulatory environment for biological therapeutics and vaccines.

 

Purpose & Disclaimer: The intent of this update is to provide the global regulatory agencies’ updates and new or revised documents during the period stated here. The items listed should neither be considered comprehensive nor exhaustive of all updates from the regulatory agencies but as such, the list contains items that the WuXi Biologics’ Regulatory Affairs team deems relevant to our potential or existing clients and partners developing biological therapeutics and vaccines. Therefore, this update is for information purposes only and is provided “as is” without any warranty, expressed or implied, as to the completeness or accuracy of the contents or its use or fitness for a particular purpose. Without limiting the generality of the foregoing, the document and information contained therein should not be construed as regulatory advice or representing, speaking or acting for any regulatory agency. The information is provided to support your efforts to remain informed and should not be used as a substitute for your own regulatory due diligence or actions.

 

Quick Links to Agency Sections:

 

FDA (U.S. Food and Drug Administration)

 

Frequently Asked Questions (FAQs): Electronic Submissions Program for CBER-Regulated Products (Including vaccines) – Jan 2022

 

The FDA updated the FAQs on eCTD submission for CBER-regulated products on Jan 2022. Below is the question list. Please follow the links for detailed answers.

 

 

Pre-Launch Activities Importation Requests (PLAIR) – Mar 2022

 

This guidance finalized the July 2013 draft guidance of the same title, which announced the agency’s approach in regulating the importation of unapproved finished form drug products by an applicant preparing to launch the product in the U.S. based on anticipated approval of a pending new drug application (NDA) or abbreviated new drug application (ANDA) and to facilitate product availability to patients upon approval. This guidance “adopts most elements of the PLAIR program announced in the July 2013 draft guidance, updates the information that should be submitted to FDA in a PLAIR, describes when and how a PLAIR can be submitted, and explains the circumstances under which the Agency intends to grant a PLAIR”. This guidance also applies to unapproved biologics licensing applications (BLAs) regulated by the Center for Drug Evaluation and Research (CDER), and unapproved combination products assigned to CDER (21 CFR part 3) for which NDA, ANDA, or BLA approval is anticipated.

 

Other FDA Drug Development and Quality Guideline Updates

 

Other FDA Regulatory Submission and Procedure Updates

 

Other FDA Vaccines, Gene Therapy, and Advanced Therapy Medicinal Products Updates

 

Other FDA Coronavirus Disease (COVID-19) Updates

 

Other FDA Updates

 

 EU (European Union) / EMA (European Medicines Agency)

 

Regulatory Harmonisation of Clinical Trials in the EU: Clinical Trials Regulation to Enter into Application and New Clinical Trials Information System Launched – Jan 2022 to Mar 2022

 

The Clinical Trials Regulation (CTR, Regulation (EU) No 536/2014) went into application on 31 January 2022, replacing the Clinical Trials Directive (EC) No. 2001/20/EC. The Regulation aims to harmonise the submission, assessment and supervision processes for clinical trials in the European Union (EU). Instead of submitting clinical trial applications separately to national competent authorities and ethics committees in each country to gain regulatory approval for clinical trials, the CTR enables sponsors to submit one online application via a new online platform, Clinical Trials Information System (CTIS), for approval to run a clinical trial in several European countries and to make it more efficient to carry out multinational trials. The CTIS system was launched on the same day with the CTR. It is a single-entry point for both sponsors and regulators for the submission and assessment of clinical trial data and also includes a public searchable database for healthcare professionals, patients and the general public.

A three-year transition period for clinical trial sponsors is foreseen under the CTR. Aiming to help both the sponsors and regulators to prepare for using the CTIS, EMA is delivering an Online Modular Training Programme which consists of several modules, covering the full lifecycle of clinical trial submission, authorisation and supervision.

The following are the websites to reference for more information:

 

Update-Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials – Feb 2022

 

And

 

Update-Guideline on the Requirements to the Chemical and Pharmaceutical Quality Documentation Concerning Investigational Medicinal Products in Clinical Trials Feb 2022

 

These two updated guidelines with regard to the documentation of Investigation Medicinal Products in clinical trials went into effect on 31 January 2022 after the acceptance of the second revision. The major updates to both guidelines are “Changes to the investigational medicinal product and auxiliary medicinal product with a need to request a substantial modification to the IMPD (Investigational Medicinal Products Documentation)”. Aiming to be in compliance with the Clinical Trial Regulation (CTR), the updates of both guidelines specify the submission scenarios for changes of “Substantial modification” and “Non-substantial modification” to IMP (Investigational Medicinal Products) /auxiliary medicinal product quality data and give a list of examples for changes in IMPs containing biological active substances, chemically defined or herbal drug substances, and their classification. The list does not claim to be exhaustive in the guideline, so when submitting a modified IMPD, the sponsor should decide on a case-by-case basis on how to classify the changes and how to submit the changes. In case of doubt, the sponsor should consult the Reporting Member State.

 

Questions and Answers for Marketing Authorisation Holders / Applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 Referral on Nitrosamine Impurities in Human Medicinal Products – (Updated) Jan 2022 to Mar 2022

 

Five updates were made for this guidance after two revisions in January and March, respectively. Compared with the last version, Q&A 4, 8, 10 and 15 were revised (briefly listed below) and Annex 1 was added as well:

 

Q&A 4: What are the currently identified risk factors for presence of nitrosamines?

 

Risk factors linked exclusively with the manufacturing process and storage of active substance, and/or the risk factors associated with manufacture and storage of the finished product, and the risk factors specifically linked to GMP aspects were grouped as root causes to date in this part.

 

Q&A 8: How should confirmatory tests be conducted by MAHs and manufacturers?

 

Several considerations of the confirmatory testing including samples, number of batches, strengths, development of analytical methods are discussed and recommended to MAHs and manufacturers.

 

Q&A 10: Which limits apply for nitrosamines in medicinal products?

 

The different scenarios based on identified nitrosamines are specified and calculation methods of the limits in line with ICH M7 (R1), ICH S9, ICH Q3A(R2) and Q3B(R2) guideline are provided.

 

Q&A 15: When should a test for nitrosamines be included in the MA dossier?

 

The general considerations of control point selection (final products, API or intermediate) for nitrosamines and testing of raw materials (e.g., excipients) are introduced. The exceptions from routine testing may be possible if the root cause of contamination is demonstrated to be well-understood. Moreover, Annex 1 is added for the decision tree with control options for products containing multiple N-nitrosamines.

 

CMDh Practical Guidance for Marketing Authorisation Holders of Nationally Authorised Products (incl. MRP/DCP) in Relation to the Art. 5(3) Referral on Nitrosamines (Updated) – Jan 2022

 

This document aims to give additional guidance and explain the necessary steps for fulfilling the requested risk evaluation, specifically for nationally authorized products, which is in line with the above Q&A for the Art.5.3 referral on nitrosamine impurities (Questions and Answers for Marketing Authorisation Holders / Applicants on the CHMP Opinion for the Article 5(3) of Regulation (EC) No 726/2004 Referral on Nitrosamine Impurities in Human Medicinal Products). Two questions (Question 1.5, 1.6) were updated and one question (Question 1.2) was added in the guidance.

 

For Q&A 1.6: What is the approach for new and ongoing marketing authorization applications (MAA)?

 

The potential presence of nitrosamines will be evaluated as part of the marketing authorization application for MAH as claimed. The approaches of risk assessment and risk evaluation on nitrosamines are described for the stages of “At the submission stage” and “During the MA evaluation procedure”.

 

Regulation on EMA’s Extended Mandate Becomes Applicable – Mar 2022

 

The regulation aims to reinforce the EMA’s role in crisis preparedness and management of medicinal products and medical devices. The EMA will establish a number of organizations to manage new tasks such as monitoring medicine shortages, reporting shortages of critical medicines during a crisis and coordinating responses of EU/EAA to the shortages of critical medical devices and in vitro diagnostics in crisis. As part of the legislation, an MSSG (Medicines Shortages Steering Group) supported by a SPOC (Single Point of Contact) and ETF (Emergency Task Force) have been established. The EMA will hold a meeting on 1 April to explain the plan and timeline.

 

Eudralex Volume 4 -Annex 21- Importation of Medicinal Products – Feb 2022

 

The new Annex 21 of Volume 4 of the EU GMP Guidelines has finally been published on February 21, 2022 and will enter into force on August 21, 2022. This new annex summarizes the GMP requirements and principles for Manufacturing Import Authorization (MIA) holders of human, investigational, and veterinary medicinal products from outside the EU/EEA. As described in this guidance, the investigational medicinal products which are regulated by Regulation (EU) 536/2014 have been added to the scope, but the medicinal products entering the EU/EEA for export only, and the products are neither processed in any way nor released for placing on the EU/EEA market are not covered by this Annex. It covers the aspects of importation including regulation basis, scope, general principles, Pharmaceutical Quality System, Premises and equipment, Documentation, Operations, Complaints, Quality Defects and Product Recalls.

 

Other EMA Drug Development and Quality Guideline Updates

 

 

Other EMA & EC Regulatory Submission and Procedure Updates

 

 

Other EMA Vaccines, Gene Therapy, and Advanced Therapy Medicinal Products Updates

 

 

Other EMA & EC Coronavirus Disease (COVID-19) Updates

 

 

Other EMA Updates

 

 

TGA (Therapeutic Goods Administration)

 

Consultation: Priority Review Pathway for Biologicals: Feasibility, Potential Eligibility Criteria and Determination Process – Feb 2022

 

The Therapeutic Goods Administration (TGA) opened the consultation for the “Priority Review Pathway for Biologicals” on Feb 28 and closed on Apr 1. The TGA was seeking advice regarding the proposed eligibility criteria, determination process and other considerations and the proposed process is outlined in Consultation paper – Priority Review Pathway for Biologicals: Feasibility, Potential Eligibility Criteria and Determination Process. The main contents of the Consultation paper are given below:

 

  • The priority review will be premised on a full dossier of data and the following 4 proposed criteria have to be met: Criterion 1: New biologics or new use; Criterion 2: Life-threatening disease or seriously debilitating condition; Criterion 3: Fulfills an unmet clinical need or clinically significant improvement over already approved therapeutic goods; and Criterion 4: Major therapeutic advantage.
  • The proposed process is divided into several steps: Optional pre-submission meeting; Notification of intent to lodge determination application; Assessment of determination application; and Determination decision.
  • A new fee is proposed to apply to the Priority Review pathway.

 

Based on the advice the TGA received, a priority pathway will be carried out for the pre-market assessment and registration of new biologicals that address unmet clinical needs. Revisions to the Therapeutic Goods Regulations 1990 is required accordingly.

 

Other TGA Regulatory Submission and Procedure Updates

 

 

Health Canada

 

Health Canada Regulatory Submission and Procedure Updates

 

WHO (World Health Organization)

 

WHO Coronavirus Disease (COVID-19) Updates

 

MHRA 

 

Marketing Authorisation Holders’ Submission of Nitrosamine Risk Evaluation, Risk Assessment and Confirmatory Testing – (Updated) Mar 2022

 

In accordance with the CHMP opinion under Article 5 (3) of Regulation (EC) No. 726/2004 on the presence of nitrosamine impurities in human medicinal products, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK updated this guidance for MAHs to review their manufacturing processes to identify and, if found, to mitigate the risk of nitrosamine impurities being present. The updates focus on reviewing the API and finished product manufacturing processes by MAHs and manufacturers in light of the arrangements for preventing nitrosamine formation as well as contamination or cross-contamination. This should take into account their knowledge of the manufacturing processes as well as the potential sources of nitrosamine impurities. The deadline for submission of the 3 steps of risk evaluation, assessment and confirmation as well as the coordinate documentation like templates and tables are also updated in this guidance.

 

MHRA Coronavirus Disease (COVID-19) Updates

 

 

PMDA (Pharmaceuticals and Medical Devices Agency)

 

PMDA Drug Development and Quality Guideline Updates

 

ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use)

ich-logo

 

ICH Drug Development and Quality Guideline Updates

  • Q2 (R2) / Q14 Analytical Procedure Development and Revision of Q2(R1) Analytical Validation 2022-03-22

 

Other ICH Updates

 

EDQM (European Directorate for the Quality of Medicines & HealthCare)

 

EDQM Drug Development and Quality Guideline Updates

 

 

PIC/S (Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme)

 

Revision of PIC/S GMP Guide (PE 009-16) – (Updated) Feb 2022

The PIC/S GMP Guide (PE 009-16) for Medicinal Products has been revised to include the revision of Annex 13 on the Manufacture of Investigational Medicinal Products, and a new Annex 16 on the Certification by the Authorised Person and Batch Release. These revisions were approved by the PIC/S Committee on 26 Jan 2022 and entered into force from 1 Feb 2022.

 

Aiming to harmonize the GMP guide in line with the Co-operation Agreement between PIC/S and EMA, PIC/S Annex 13 has been revised based on the new CTR regulation (EC Regulation No. 536/2014) on Clinical Trials, which will replace EU Annex 13, to keep the GMP standards equivalent.

 

PIC/S announced the adaption of EU GMP Annex 16 on Qualified Person certification and batch release in the PIC/S Annex 16. Based on a previous draft, including this annex into the GMP system, may provide additional benefits to better convey expectations related to product release and further international harmonization efforts”. The PIC/S also states, “The content of Annex 16 relating to imported medicinal products is voluntary and depends on national legislation.” Meanwhile, “All non-EEA Participating Authorities of PIC/S and Applicants have been invited to transpose Annexes 13 & 16 of the PIC/S GMP Guide into their own GMP Guides.”

 

The following guides are provided as reference:

 

 

National Medical Products Administration (NMPA)

 

Submission & Acceptance

 

Updates on the regulatory guidelines related to the acceptance and notification of drug registration applications:

 

On January 29, 2022, considering the needs for prevention and control of the pandemic, the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) adjusted the work methods relating to the acceptance of filing dossiers, the requirements for receiving submissions, and the notification of supplementary submission and inspection of manufacturing sites in epidemic control areas. On February 18, 2022, the CDE issued “Guideline for Acceptance and Review of Registration of Biological Products (Draft for Solicitation of Comments)”, open for comments from February 18 to March 4, which clarified that applicants should fill in the application form through the online system and complete online submission, following the requirements in “NMPA Notice on Online Application for Drug Registration”.

 

Updates of FAQs for submission & acceptance of drug registration:

 

In Q1 2022, CDE published 8 new Q&As related to the submission and acceptance of drug registration. Specific questions in the document are as follows (answers provided online):

 

Question 1: According to “CDE Notice on Adjusting the Work Method and Requirements for Acceptance and Receiving Filing Dossiers during the Epidemic Period”, is it necessary to prepare dossier in electronic format when submitting applications after February 7?

 

Question 2: What are the differences between the electronic format and eCTD format when submitting drug registration application materials?

 

Question 3: When multiple application forms share a set of filing dossiers, how to print the data check code on the cover of the CD box and the acceptance number on the cover of the file bag?

 

Question 4: What are the requirements for the cover of the file bag submitted within 5 working days after the electronic dossiers are accepted?

 

Question 5: For applications accepted after February 7, do sponsors still need to submit a CD-ROM for verification of drug registration?

 

Question 6: According to “CDE Notice on Adjusting the Work Method and Requirements for Acceptance and Receiving Filing Dossiers during the Epidemic Period”, what are the requirements regarding the transmission time, content and format of the email about the dossier mailing information?

 

Question 7: According to “CDE Notice on Adjusting the Work Method and Requirements for Acceptance and Receiving Filing Dossiers during the Epidemic Period”, which parcels do not meet CDE’s requirements about express delivery?

 

Question 8: What are the requirements for the encapsulated file bag of the CD box of electronic dossiers?

 

References

 

Marketing Application Review

 

In order to encourage research and development of new drugs, the CDE drafted and issued “Working Procedure to Accelerate the Review Process of Marketing Application of Innovative Drugs (Trial Version)” on February 21, 2022. The draft procedure is open for solicitation of comments within 2 weeks starting from the draft’s release. This working procedure applies to innovative drugs which are incorporated in the breakthrough therapeutic drug procedure and applies to the research stage when the exploratory clinical trial has been completed, and the conditions to carry out pivotal clinical trials are met and before approval of marketing application. The working procedure explains the process of communication, verification and inspection, acceptance and task assignment, professional review, comprehensive review, issuance of approval, etc., and emphasizes the responsibilities of the applicant for drug development.

 

References

 

GMP Appendix for Investigational Drugs

 

In order to further standardize the manufacturing of investigational drugs for clinical trial use and to support the research and development of new drugs, the NMPA drafted the “Drug Good Manufacturing Practice (GMP) – Appendix of Investigational Drugs (Draft for Solicitation of Comments)” and the “Notes for Drafting”, which were issued on January 18 and open for solicitation of public comments by February 17, 2022. This is the second round of revisions and solicitation for comments for the document.

 

In this revision, terms and information regarding the sample retention of raw materials, excipients and packaging materials, and bacteria (virus) seeds and cell lines/strains used for production and testing were updated. The quality agreement signed with the contracted company should clearly state that the applicant could perform inspections or on-site audits of the contracted company and clinical trial institutions are allowed for operations of adding additional labels. The revision updated the amount and duration of sample retention for investigational drugs, changing from at least 3 times of full testing in the 2018 version to at least 2 times of full testing, and prohibited the transfer of investigational drugs between clinical trial institutions. The appendix of APIs for clinical trials is deleted in this revision, and responsibility of the applicant for the drug product, -while the associated APIs are managed by the applicant, is emphasized. The applicant is required to have a responsible person in charge of release of every batch of investigational drugs.

 

References

 

Key Points for MAH Inspection

 

On Mar 31, 2022, the NMPA drafted and issued the document “Key Points for Inspection of Drug Marketing Authorization Holder (Draft for Solicitation of Comments)”, which aims to carry out the “Drug Administration Law of the People’s Republic of China” and the “Vaccine Administration Law of the People’s Republic of China”, and fully implement the responsibilities of the drug marketing authorization holder (MAH) for the safety, efficacy and quality controllability of drugs during the entire process of drug development, production, distribution and use, and to further regulate the supervision and inspection activities on the MAH. The deadline for solicitation of comments is April 30. This is the second round of revisions and solicitation for comments for the document.

 

Previously on March 2, 2020, the NMPA released and solicited public opinions on the first draft of “Key Points for Inspection of Drug Marketing Authorization Holder (Draft for Solicitation of Comments)”, together with “Procedure for Inspection of Drug Marketing Authorization Holder (Draft for Solicitation of Comments)”.

 

The current version (second revision) specifies the scope of supervision and inspection activities conducted on domestic MAHs. It specifies that MAHs are responsible for the whole product life cycle including manufacturing management, material management, quality control and quality assurance, documents and records, sales management and post-marketing study. The regulatory authorities will carry out inspections of these responsibilities and obligations of the MAH to ensure compliance.

 

Detailed requirements in the document include the following: It is required to clarify the organization structure and job responsibilities of key personnel, and to implement the responsibilities and obligations of a domestic MAH regarding the compliance with GMP, GVP and other relevant requirements; management of manufacturing activities including the confirmation of facilities and equipment, supervision of the manufacturing process, process validation, on-site audit, review of manufacturing procedures, product information rules, evaluation of multi-product facility, reprocessing and recovery, leaflet and labels, and storage conditions; management of materials including material suppliers, material check and acceptance, storage and transportation, and material handling; management of quality control and quality assurance including system audit, inspection, testing methods, stability study, review of record, deviation and corrective and preventive actions, self-inspection, and quality review; management of documents and records including technical files, document system, procedure of document management, and requirements for record keeping and archiving; management of sales including contracted sales, contracted storage and transportation, and recall; management of post-marketing study and risk including risk management, post-marketing study, change and re-registration, plan for handling safety events, and communication mechanisms. Other requirements include production suspension report of drug in shortage, annual report, and responsibility of compensation.

 

In addition, supervision and inspection of vaccine MAHs are specified, including vaccine contract manufacturing, vaccine sales management, vaccine risk control, vaccine liability compulsory insurance and suspension report, and vaccine information disclosure.

 

References

 

Chinese Pharmacopoeia

 

In Q1 2022, the Chinese Pharmacopeia Commission (ChPC) issued the following drafts open for solicitation of public comments: “Revised Draft of Drug Excipient Standard for Glacial Acetic Acid”, “Draft of Drug Excipient Standard for Polyvinyl Alcohol”, “Draft of the Second Method for General Procedure 3201 – Determination Method of Ethanol Residue”, and “Draft of Guideline for Amino Acid Analysis (Second Revision)”.

 

References

 

Pharmaceutical Packaging

 

On January 20, 2022, the China National Pharmaceutical Packaging Association (CNPPA) issued the “Guideline for Equality/Interchangeability and Compatibility Study for Changes in Package of Commercial Drugs” (T/CNPPA 3019-2022), including Chinese and English versions, which were implemented starting from January 20, 2022.

 

This guideline should be read in conjunction with the “Technical Guidelines for Study of Pharmaceutical Changes of Commercial Chemical Drugs (Trial Version)” issued by the CDE in 2021, and the “Technical Guideline for Study of Changes in Pharmaceutical Packaging Materials” (T/CNPPA 3009-2020) issued by the CNPPA in 2020.

 

This guideline proposes specific working methods based on the guiding concepts from the above-mentioned guidelines. The methods given in this guideline are not exclusive. The equivalence/interchangeability and compatibility study of pharmaceutical packaging materials is to evaluate the applicability (including protection, functionality, safety and compatibility) of the pharmaceutical packaging materials, and to determine the acceptability of the risk regarding applicability before and after the change, rather than to determine whether the applicability is the same. The principle of pairwise comparison and the principle of determining equivalence/interchangeability in this guideline may also provide reference for other pairwise comparative studies related to pharmaceutical packaging materials.

 

References

 

COVID-19 Drugs & Vaccines

 

COVID-19 Drugs:

 

On Feb 12, 2022, the NMPA granted conditional approval under emergency for import registration of Pfizer’s COVID-19 antiviral therapeutic drug which is a combined package of Nemartevir Tablets/Ritonavir Tablets. On March 15, 2022, the National Health Commission and the State Administration of Traditional Chinese Medicine jointly issued the “Protocol for Diagnosis and Treatment of COVID-19 (9th Trial Version)”, which incorporated two specific anti-coronavirus drugs approved by NMPA: Paxlovid (PF-07321332/Ritonavir tablets) and domestic monoclonal antibodies (Amubarvimab/Romlusevimab injection). The current diagnosis and treatment protocol includes four antiviral treatment methods: Paxlovid (PF-07321332/Ritonavir tablets), Amubarvimab/Romlusevimab injection, COVID-19 human immunoglobulin intravenous injection, and convalescent plasma of recovered patients.

 

COVID-19 Vaccines:

 

On March 1, 2022, NMPA granted conditional marketing approval for a recombinant protein COVID-19 vaccine from Anhui Zhifei Longkema Biopharmaceutical Co., LTD. This vaccine was previously granted for emergency use on Mar 16, 2021. By Q1 2022, the NMPA has approved a total of seven vaccines for the prevention of COVID-19, five are “conditional approval for marketing authorization” and two are “for emergency use” [1]. Information and comparison of the seven vaccines are summarized as follows:

 

Approval

Company

Vaccine Type

Characteristics

2020-12-30

Conditional Approval

Beijing Institute of Biological Products Co., Ltd (Sinopharm)

Inactivated vaccine

(Vero cell)

First approved COVID-19 vaccine in China; Produced through virus culture, harvest, inactivation and purification

2021-02-05

Conditional Approval

Sinovac Research and Development Co., Ltd

Inactivated vaccine

(Vero cell)

Similar technical pathway with the vaccine by Beijing Institute of Biological Products

2021-02-25

Conditional Approval

Wuhan Institute of Biological Products Co., Ltd (Sinopharm)

Inactivated vaccine

(Vero cell)

2021-02-25

Conditional Approval

CanSino Biologics Inc.

Recombinant adenovirus vectored vaccine

First single-dose COVID-19 vaccine in China; Using adenovirus vector to carry a gene encoding antigen of COVID-19 virus

2022-03-01

Conditional Approval

Anhui Zhifei Longkema Biopharmaceutical Co., Ltd

Recombinant protein vaccine

First COVID-19 recombinant protein vaccine in the world; Produced through gene engineering techniques to express the protein in CHO cells and purification

2021-05-14

Emergency Use

Shenzhen Kangtai Biological Products Co., Ltd.

Inactivated vaccine

(Vero cell)

Similar technical pathway with the vaccine by Beijing Institute of Biological Products

2021-06-09

Emergency Use

Institute of Medical Biology Chinese Academy of Medical Sciences

Inactivated vaccine

(Vero cell)

 

Note [1]: According to the “Vaccine Administration Law”, “Emergency use” can only be applied to vaccines when there is a critical public health emergency or other emergencies that seriously threaten the public health. The national health authorities will, based on the needs to prevent and control infectious diseases, propose the emergency use of vaccines. The vaccines could be used within a certain range and within a certain period after approval of the proposal by the NMPA.

 

Reference

List