52 regulatory updates in Pharma, MedTech and Biologics for March 2021

52 regulatory updates in Pharma, MedTech and Biologics for March 2021

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This post is a snapshot of 52 of the 2,300+ updates we captured from around the globe for March 2021.

Albania 

Normative Act No.7 on Amendments to the Normative Act No.1 (10 January 2021) on the Approval of the Agreement on Manufacturing and Supply Between Pfizer Export BV and multiple parties in Albania  

Council of Ministers  |  12 March 2021

The agreement amends the Normative Act No.1 (10 January 2021) on the Approval of the Agreement of Manufacturing and Supply Between Pfizer Export BV and the Ministry of Health and Social Protection of Albania, Public Health of Albania and Ministry of State. It Reconstructs and Authorizes the Procedure to Allow and Administer COVID-19 Vaccines in the Republic of Albania and Their Usage in the Population – Approved by Law No.2/2021. Based on this normative act, Covid-19 vaccines that are allowed in Albania are EMA/FDA approved or approved by other certifying bodies of the manufacturing countries of covid-19 vaccines. 

Australia 

Advertising COVID-19 Vaccines to the Australian Public

Therapeutic Goods Administration (TGA)  |  2 March 2021

The advertising of prescription medicines (including vaccines) to consumers is generally prohibited in Australia. However, some exceptions (such as the use of authorized materials) are in place to support the roll-out of COVID-19 vaccines across Australia. This guideline explains how vaccine providers and other parties can lawfully provide information about and promote COVID-19 vaccines without risking a breach of the prohibition on advertising prescription medicines.

TGA Adopts Access Consortium Guidance for Fast-Tracking Authorisations of Modified COVID-19 Vaccines for Variants [Australia, Canada, Singapore, Switzerland, United Kingdom]

Therapeutic Goods Administration (TGA)  |  5 March 2021

TGA has adopted guidance developed by the Access Consortium. The guidance lays out what information the medicines regulators would need in order to approve any modifications to authorized COVID-19 vaccines, should virus mutations make them less effective at preventing the disease. This guidance is in addition to the earlier Access Consortium statement on COVID-19 vaccines evidence. 

Belgium

A Common Central Headquarters for the FPS Public Health, the INAMI and the FAMHP

Federal Agency for Medicines and Health Products (FAMHP)  |  1 March 2021

On 1 March 2021, the FPS Public Health, Food Chain Safety and Environment (SPF SPSCAE), the National Institute for Sickness and Invalidity Insurance (INAMI) and the Federal Agency for Medicines and Health Products (FAMHP) move into a common building in the center of Brussels. This move will strengthen cooperation between the three organizations in a common vision: “Working together for health in a spirit of sustainable development”.

Brazil

Resolution RDC – RDC No. 474 of 3 March 2021

Brazilian Health Surveillance Agency (ANVISA)  |  3 March 2021

This Resolution amends Resolution No. 352 of 20 March 2020, which provides for prior authorization for the purpose of exporting raw materials, semi-finished products, bulk products or finished pharmaceutical products intended to combat COVID -19. The amendment added the Covid-19 vaccines and the medical oxygen gas to the list of drugs that depend on prior consent from Anvisa for export purposes.

Law No. 14. 124 of 10 March 2021

Brazilian Health Surveillance Agency (ANVISA)  |  10 March 2021

This Law provides for exceptional measures related to the purchase of vaccines and supplies and the contracting of goods and services for logistics, information and communication technology, social and advertising communication and training for vaccination against Covid-19 and the National Operationalization Plan of Vaccination against Covid-19.

Bulgaria

Notification: Executive Agency for Medicines has ordered the release of blocked amounts of Covid 19 Vaccine AstraZeneca

Bulgarian Drug Agency (BDA)  |  19 March 2021

The Executive Agency for Medicines has ordered the release of blocked amounts of Covid 19 Vaccine AstraZeneca available in the country following a preliminary review of thrombo-embolic events following vaccination by the European Medicines Agency.

The position of the EMA’s Pharmacovigilance Committee (PRAC) is that the benefit-risk balance of this vaccine remains positive, with no causal link to the vaccine and therefore its use can continue.

There is no data on safety issues for specific batches of the vaccine.

In connection with a reported case of a serious adverse drug reaction in Bulgaria, the results of the forensic examination did not establish data on vascular thrombosis or other changes related to the vaccine

Canada

Interim Order No. 2 Respecting Drugs, Medical Devices and Foods for a Special Dietary Purpose in Relation to COVID-19

Ministry of Health of Canada  |  30 March 2021

The COVID-19 pandemic has created an urgent need for drugs, biocides, medical devices and foods for a special dietary purpose, and affected their supply in Canada. To help prevent or alleviate shortages of these products, the Minister of Health has signed an interim order (IO). It allows products that may not fully meet Canadian regulatory requirements, but are manufactured to comparable standards, to be imported and sold using exceptional importation. The IO also makes it mandatory to report shortages of critical medical devices to Health Canada during the pandemic.

Interim Order No. 2 Respecting the Importation and Sale of Medical Devices for Use in Relation to COVID-19

Health Canada  |  1 March 2021

Health Canada created the Interim Order respecting the importation and sale of medical devices for use in relation to COVID-19 (Interim Order No. 1) to accelerate access to certain medical devices in Canada during the COVID-19 outbreak. Interim Order No. 1 was set to expire in March 2021. For this reason, Health Canada has issued a second interim order. This Interim Order No. 2 extends the flexibilities of the first so that devices can continue to be sold and imported in Canada.

Chile

Exempt Resolution No. 490

Public Health Institute of Chile (ISP)  |  23 March 2021

This Exempt Resolution determines the administrative procedures of the Chilean Public Health Institute that will remain in force for the duration of the Covid-19 pandemic in the country.

China

NIFDC Notice on Suspending the Issuance of Biological Product Batch Release Import Inspection Report

National Institutes for Food and Drug Control (NIFDC)  |  2 March 2021

According to requirements specified in article 5 of the “Provisions for Lot Release of Biological Products”, the biological product batch release certificate can be used as the custom clearance certificate for vaccines under application for first-time importation. The import inspection report issued by NIFDC is no longer required since 1 March 2021.

Procedure for Emergency Review and Approval of Medical Devices (Revised Draft for Comments)

National Medical Products Administration (NMPA)  |  4 March 2021

This procedure applies to the fast-track review and approval of medical devices during public health emergencies. Products eligible for such procedure include class III domestic devices and imported devices that can meet the urgent need during emergencies but no products of the type are approved for marketing in China; or products of the same type that are granted marketing authorization but there is a shortage of supply. The document specifies requirements and application process of medical device emergency review and approval. The application form for such procedure is attached at the end as annex.

Denmark

COVID-19: The Danish Medicines Agency Again Includes for a Limited Period All Medicine Packages in Medicine Prices

Danish Medicines Agency (DKMA)  |  5 March 2021

As part of preventing potential supply problems for medicines during the Corona pandemic, the Danish Medicines Agency has again decided to change its usual practice for including packages in Medicinal Prices. All notified drug packages, regardless of delivery capacity, will thus be included in Medicine Prices for a limited period. This change takes effect from the Medicine Price Period, which takes effect on 22 March 2021, and up to and including the price period that runs from 14 June 2021 to 27 June 2021.

EFPIA

Maintaining the Exchange of Critical Health Data

European Federation of Pharmaceutical Industries and Associations (EFPIA)  |  

1 March 2021

We welcome the draft adequacy decision on the UK data protection regime issued by the European Commission on 19th February 2021. Protecting the benefits of the free flow of personal data must be a top priority. The absence of an adequacy decision would negatively impact the UK and EU health sectors and their patients. We urge the European Data Protection Board and the European Parliament to support the ruling and National Governments to approve the draft decision.

Egypt

Guideline for the Rules Regulating the Import and Customs Clearance for Pharmaceutical Products, Raw Materials and Packaging Requirements

Egyptian Drug Authority (EDA)  |  7 March 2021

This guideline details the rules that regulate the import and release of pharmaceutical raw materials and chemicals in addition to specifying the packaging requirements that go into manufacturing local products registered or under registration with the Egyptian Drug Authority. It also details the requirements for obtaining importing permits for herbal, biological and narcotic drugs.

European Union

EMA and Health Canada Publish Clinical Data Used to Support Their Authorisations of the Moderna COVID-19 Vaccine

European Medicines Agency (EMA)  |  2 March 2021

Openness and transparency are key to building confidence in COVID-19 vaccines. Today, EMA and Health Canada collaboratively published the full clinical data reviewed as part of their authorisations of the Moderna COVID-19 vaccine.

Pilot Project ‘Market Launch of Centrally Authorised Products’

European Commission (EC)  |  25 March 2021

From 25 March 2021, marketing authorisation applicants for orphan medicines and medicines to treat cancer will be invited to take part in a pilot project by declaring their market launch intentions on a voluntary and confidential basis. The pilot aims to help regulators understand why delays may occur in the marketing of certain medicines in EU Member States after they receive a marketing authorisation. EMA will invite marketing authorisation applicants to share this information via an online survey at the time of validation or when they receive the CHMP opinion. They will be also asked to provide feedback on challenges and limiting factors they face in ensuring the availability of their medicines in the EU. The pilot project will run for 18 months, until August 2022.


COVID-19: Latest Updates

European Medicines Agency (EMA) | 31 March 2021

The European Medicines Agency (EMA) is contributing to global efforts to save lives during the COVID-19 pandemic by expediting the development and approval of safe and effective treatments and vaccines, supporting the continued availability of medicines in the European Union (EU), and providing reliable information to patients and healthcare professionals. This document encloses the latest updates on the COVID-19 pandemic from the European Medicines Agency (EMA), including all news and press releases.

Finland

Extension of Temporary Special Permits in the Event of an Emergency During the COVID-19 Pandemic

Finnish Medicines Agency (FIMEA)  |  24 March 2021

This document lays down the special permits for drugs under a temporary special authorization due to the COVID-19 pandemic.

Guatemala

Request for Expedited Marketing Authorization of Covid-19 Vaccines for Emergency Use

Ministry of Public Health and Welfare (MSPAS)  |  4 March 2021

Hong Kong

Pharmaceutical Products Recall Guidelines

Drug Office of Hong Kong  |  3 March 2021

This guidance is intended to ensure that in the event of a necessary recall, the recall operations are effectively and efficiently carried out by the manufacturer, importer, distributor, or certificate holder of a pharmaceutical product in order to safeguard public health. It covers content of the following aspects: introduction and definitions; stages of recall procedure; notification of a pharmaceutical product problem; initiation of recall/information required for assessment of recall; assessment of recall; communication to public; responsibilities of licensee; evaluation of the recall; and reinstatement of supply. This current version updates contact information of the administrative authority.

Jordan

Circular No. 2/1/8/11664: COVID-19 PCR Test

Jordan Food and Drug Administration (JFDA)  |  14 March 2021

This circular announces that the period for re-testing participants in clinical trials has been reduced from 14 days to 7 days from the date of the last test.

Malaysia

Registration Requirements for COVID-19 Vaccine to Be Approved for Registration with the Condition to Be Sold and Supplied Only to the Government or a Party Authorized by the Government

National Pharmaceutical Regulatory Agency (NPRA)  |  10 March 2021

The National Pharmaceutical Regulatory Agency published this decision to inform product registration holders of the obligation to ensure that products will be sold or supplied only to the government or other party authorized by the government.

Mexico

COFEPRIS Optimizes Regulatory Procedures of the New Molecules Committee, Based on the Best Practices of the European Medicines Agency

Federal Commission for the Protection against Sanitary Risk (COFEPRIS)  |  4 March 2021

The COFEPRIS is detailing, step by step, the most recent changes to the New Molecules Committee approach to drug evaluations. These changes are based on the principles of the European Medicines Agency.

Peru

Documents Submission Form to Comply with Specific Obligations of Certain Pharmaceutical and Biological Products with a Conditional Registration

Directorate General of Drug Supplies and Drugs (Digemid)  |  4 March 2021

Philippines

Memorandum No. 2021-009: Minimum Performance Requirements for COVID-19 Test Kits Used for SARS-CoV-2 Infection

Food and Drug Administration of the Philippines  |  12 March 2021

This Memorandum aims to set the minimum performance requirement for COVID-19 test kits. In addition, it aims to provide specific guidelines on the re-evaluation of product performance of COVID-19 test kits issued with Special Certification by FDA.

Russia

Draft Resolution on the Approval of a List of Medicines for Medical Use that Are Subject to the Quantitative Accounting

Government of the Russian Federation  |  3 March 2021

This draft resolution is aimed at approval of the attached list of medicines that are subject to the quantitative accounting, and invalidation of the Orders Nos. 183n and 471n, as well as certain provisions of the Orders Nos. 634n, 882n and 149n.

Resolution No. 430 on Particularities of Circulation of Medical Devices, Including State Registration of a Series (Batch) of Medical Devices. Consolidated Version of 6 March 2021

Government of the Russian Federation  |  6 March 2021

This document approves that medicines intended for COVID-19 will be subject to fast registration. The latest amendment provides for electronic submission of information on imported unregistered medical devices through the automated information system of the Federal Service for Supervision in Healthcare.

Saudi Arabia

Application for variation to a marketing authorisation

Saudi Food and Drug Authority (SFDA)  |  25 March 2021

Singapore

Guidelines on Good Manufacturing Practice for Cell, Tissue and Gene Therapy Products

Health Sciences Authority (HSA)  |  March 2021

The HSA GMP guidelines for Cells, Tissues and Gene Therapy Products (CTGTP) incorporate the requirements of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products and the European Commission Guidelines on Good Manufacturing Practice specific to Advanced Therapy Medicinal Products. These Guidelines are applicable to the manufacture of CTGTP which are subjected to processing other than minimal manipulation and intended for medical use in humans.

Clinical Trials Guidance. Determination of Whether a Clinical Trial Requires a Clinical Trial Authorization (CTA), Clinical Trial Notification (CTN) or Clinical Trial Certificate (CTC)

Health Sciences Authority (HSA)  |  1 March 2021

The purpose of this document is to provide guidance to sponsors and investigators on determining whether a clinical trial requires clinical trial authorization (CTA), clinical trial notification (CTN) or clinical trial certificate (CTC).

Slovak Republic

Announcement of QPPV or Contact Person Appointment and Their Changes

State Institute for Drug Control (SIDC)  |  1 March 2021

The guideline establishes a uniform procedure of notifying designated persons and their contact details to the position of person responsible for safety oversight of medicinal products for human use (QPPV).

South Korea

MFDS Guidance on Storage and Transportation Management for COVID-19 Vaccines – for COVID-19 Vaccination Response Team, Manufacturers, Importers, Distributors (Contractors) and Vaccinating Medical Institutes

Ministry of Food and Drug Safety (MFDS)  |  1 March 2021

Published jointly by the Ministry of Food and Drug Safety (MFDS) and the Korea Disease Control and Prevention Agency (KDCA), this guidance specifies the additional requirements and consideration in storing and transporting the COVID-19 vaccines throughout the distribution channel from overseas manufacturers to vaccinating medical institutes, including the reporting requirements at each stage to the COVID-19 Vaccination Response Team (the task force team for COVID-19 vaccination at the KDCA). It also explains the product-specific requirements for vaccines from AstraZeneca, Pfizer and Janssen. The other general requirements for storing and transporting biological medicinal products, not mentioned in this guidance, should be referred to the Drug Safety Rules Article 62(7) and the Rules on Manufacturing and Sales Management for Biological Products.

Sweden

Proposal for Adjustment of Fees in the Ordinance (2010:1167) on Fees for State Control of Medicines

Swedish Medical Products Agency (MPA)  |  1 March 2021

The Medical Products Agency requests the fees in the ordinance (2010: 1167) on fees for state control of medicines to be increased with this proposal. The Medical Products Agency charges application and annual fees from companies for processing and investigating applications for marketing authorizations to sell products on the Swedish market and for follow-up and supervision of the products. The regulation also regulates application and annual fees for the manufacture of medicines.

The Medical Products Agency Proposes Increased Fees

Swedish Medical Products Agency (MPA)  |  2 March 2021

This news of the Medical Products Agency describes the proposal to the government to increase the fees for the state control of medicines. The aim of the proposal is to receive full cost coverage for the Agency activities and thus the conditions to fulfill its tasks.

Product Information Exemptions for COVID-19 Vaccines

Swedish Medical Products Agency (MPA)  |  8 March 2021

This document includes information about the exemptions for the Covid-19 vaccines that will be distributed in Sweden. In Sweden, all authorized medicinal products must have approved product information (summary of product characteristics, information sheet and labelling). Medicinal products on the Swedish market usually have product information in Swedish to facilitate the manufacture and distribution of coronavirus vaccines. For this reason, it is possible to apply for an exemption.

Switzerland

COVID-19 – Pandemic – Medical Face Mask Compliance Review

Swiss Agency for Therapeutic Products (Swissmedic)  |  9 March 2021

This short document lays down the updated legal information and requirements for pharmaceutical companies when manufacturing medical face masks during the COVID-19 pandemic.

Turkey

To the Attention of Research Groups Conducting COVID-19 Vaccine Development Studies – Announcement on Vaccine Quality File

Turkish Medicines and Medical Devices Agency (TMMDA)  |  16 March 2021

This document includes explanations about quality data and immunogenicity data that should be included in the clinical trial application file for the research groups developing COVID-19 vaccine.

Ukraine

Resolution No. 146 on Approval of the Procedure of Issuing Permits for the Right to Import into, Export from or Transit Through the Territory of Ukraine of Narcotic Drugs, Psychotropic Substances and Precursors. Consolidated Version of 3 March 2021

Ukraine Cabinet of Ministers  |  3 March 2021

This document approves the attached Procedure of issuing permits for the right to import into, export from or transit through the territory of Ukraine of narcotic drugs, psychotropic substances and precursors. The latest amendment introduces some wording changes to this document.

United Kingdom

Medicines: Apply for a Parallel Import Licence

Medicines and Healthcare products Regulatory Agency (MHRA)  |  1 March 2021

This guidance explains how to get a parallel import license for your medicine in the UK, including pharmacovigilance requirements and submitting your application.

Exporting Active Substances Manufactured in Great Britain for Use in EEA and Northern Ireland

Medicines and Healthcare products Regulatory Agency (MHRA)  |  2 March 2021

This guidance explains how the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).

Medical Devices Given Exceptional Use Authorizations During the COVID-19 Pandemic

Medicines and Healthcare products Regulatory Agency (MHRA)  |  30 March 2021

List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation.

USA

COVID-19 Container Closure System and Component Changes: Glass Vials and Stoppers. Guidance for Industry

CDER and CBER  |  4 March 2021

FDA is issuing this guidance to collate recommendations for appropriate reporting categories and the content of postapproval change submissions across numerous FDA guidance documents. This guidance conveys recommendations to holders of approved new drug applications (NDAs), biologics license applications (BLAs), and abbreviated new drug applications (ANDAs) regarding the reporting and implementation of some common changes to container closure system (CCS) components.

Oncologic Drugs Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments

Food and Drug Administration (FDA)  |  12 March 2021

The Food and Drug Administration (FDA) announces a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee. The general function of the committee is to provide advice and recommendations to FDA on regulatory issues. The meeting will be held on April 27-28-29, 2021, and will be open to the public. FDA is establishing a docket for public comment on this document.

Specifications for eCTD Validation Criteria

Center for Drug Evaluation and Research (CDER)  |  15 March 2021

These specifications detail the validation criteria applied when FDA processes eCTD submissions. They provide a description of the error, an explanation of the error, the corrective steps necessary to correct the error and the severity level that has been assigned to the error.

Examples of Real-World Evidence (RWE) Used in Medical Device Regulatory Decisions

Center for Devices and Radiological Health (CDRH)  |  March 2021

In support of the U.S. FDA’s CDRH mission to protect and promote public health by ensuring the safety and effectiveness of medical devices, the agency aims to foster the use of real-world evidence (RWE) to support regulatory decision-making. To further this goal, CDRH has reviewed a sample of past decisions to identify examples leveraging RWE in premarket and postmarket decisions, selecting 90 examples of submissions that illustrate the broad spectrum of RWE usage in support of regulatory decision-making from fiscal years 2012 through 2019.

Supplemental Template for Developers of Molecular and Antigen Diagnostic COVID-19 Tests for Screening with Serial Testing

Food and Drug Administration (FDA)  |  16 March 2021

This template provides the Food and Drug Administration’s (FDA) current recommendations concerning what data and information should be submitted to FDA in support of a pre-Emergency Use Authorization (EUA) submission/EUA request for a molecular or antigen diagnostic test for SARS-CoV-2 used for screening with serial testing.

FAQs on the EUAs for Non-NIOSH Approved Respirators During the COVID-19 Pandemic

Food and Drug Administration (FDA)  |  24 March 2021

On October 15, 2020, the FDA reissued the Emergency Use Authorization (EUA) for Non-NIOSH-Approved Disposable Filtering Facepiece Respirators Manufactured in China to revise the scope of authorization to authorize for emergency use only those respirators listed in the EUA’s Appendix A as of the date of this reissuance. Similarly, on March 24, 2021, the FDA reissued the EUA for Imported, Non-NIOSH-Approved Disposable Filtering Facepiece Respirators to revise the scope of authorization to authorize for emergency use only those respirators listed in the EUA’s Exhibit 1 as of the date of this reissuance. These EUAs no longer include the eligibility criteria that were included in the previous authorization letters, meaning FDA will no longer be reviewing requests and adding new respirator models to Appendix A or Exhibit 1, respectively, based on those criteria. For more information, please see the FDA’s October press release regarding non-NIOSH-approved FFRs manufactured in China.

Meeting of the Secretary’s Advisory Committee on Human Research Protections

Department of Health and Human Services (HHS)  |  23 March 2021

Pursuant to Section 10(a) of the Federal Advisory Committee Act, U.S.C. Appendix 2, notice is hereby given that the Secretary’s Advisory Committee on Human Research Protections (SACHRP) will hold a meeting that will be open to the public on March 23-24, 2021.

WHO

Background Document on the Janssen Ad26.COV2.S (COVID-19) Vaccine

World Health Organization (WHO)   |   17 March 2021

This background document was prepared by the Strategic Advisory Group of Experts (SAGE) on Immunization Working Group on COVID-19 Vaccines to inform the discussions of SAGE at its 15 March 2021 meeting, which resulted in the issuance of the WHO interim recommendations for use of the Ad26.COV2.S (COVID-19) vaccine.

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