Regulatory Newsletter

WuXi Biologics Regulatory Updates

Quarter 2 – 2020 – Special Topic – COVID-19 Pandemic Outbreak

This document provides regulatory updates focused on the COVID-19 pandemic outbreak in both Chinese and English. For WHO, U.S., and EU updates in English proceed to section 3.1.

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: U.S. Food & Drug Administration (FDA) | European Medicines Agency (EMA) | MHRA – Medicines and Healthcare Products Regulatory Agency | Health Canada | Cross – Agency Collaboration | NMPA National Medical Products Administration

FDA

Good Manufacturing Practice Considerations for Responding to COVID-19 Infection in Employees in Drug and Biological Products Manufacturing (June 2020)

This guidance intends to provide GMP recommendations to drug and biological product manufacturers in order to prevent or mitigate potential adverse effects on the safety and quality of drugs from an infected or potentially infected employee engaged in drug manufacturing. This policy intends to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of Health and Human Services (HHS).

The following points should be taken into consideration by the manufacturers:

• Evaluate the CGMP controls regarding restriction of sick employees from production areas
• Review CGMP requirements and recommendations related to facility and equipment cleaning and sanitation and other controls that ensure materials, APIs, components, drug product containers and closures, in-process materials, and drug products are safe and meet their quality requirements
• Risk assessment of SARS-CoV-2 concerning drug safety or quality
• For biological products, the potential for the production cell line to replicate SARS-CoV-2, the capability to detect SARS-CoV-2 in current cell bank and harvest testing, the effectiveness of viral clearance and inactivation steps for SARS-CoV-2, as well as the controls in place for procedures taking place in open systems (e.g., buffer and media preparation areas) are recommended to be assessed by the manufacturers.

COVID-19 Public Health Emergency: General Considerations for Pre-IND Meeting Requests for COVID-19 Related Drugs and Biological Products (May 2020)

This guidance provides general nonclinical, clinical, and product quality considerations to assist sponsors in preparing pre-IND meeting requests for COVID-19 related drugs. This policy is intended to remain in effect only for the duration of the public health emergency related to COVID-19 declared by the Secretary of HHS. For pre-IND requests for drugs that treat or prevent COVID-19, the content requests and processes described within this guidance substitute for those used in other settings described in the draft guidance for industry Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products (December 2017).

Sponsors developing drugs for use in treatment or prevention of COVID-19 have three options for submitting their pre-IND meeting requests:

• Electronic Submissions Gateway (ESG, the preferred method)
• NextGen Portal (for CDER pre-IND meeting requests)
• Sending emails to CBERDCC_eMailSub@fda.hhs.gov (for CBER pre-IND meeting requests that cannot be sent through ESG).

Effects of the COVID-19 Public Health Emergency on Formal Meetings and User Fee Applications – Questions and Answers (May 2020)

This guidance provides answers to frequently asked questions about regulatory and policy issues related to drug development for the duration of the COVID-19 public health emergency declared by the HHS. The following are two examples of this important Q&A document:

Q: Will some PDUFA and BsUFA applications be delayed because of the COVID-19 public health emergency?

The FDA intends to focus resources on INDs, NDAs, and BLAs (both 351(a) and 351 (k) applications) for drugs or biologics related to COVID-19 or certain other life-threatening conditions. Exceptions include the initial IND 30-day safety review and other important safety issues that may emerge during IND development.

Q: Does FDA expect that PDUFA and BsUFA goal dates will be missed, or will the goal dates be extended because of the COVID-19 public health emergency?

Though the FDA is committed to working to meet the performance goals outlined in the PDUFA VI and BsUFA II goals letters, the FDA may anticipate missing a PDUFA or BsUFA goal date because of the current public health emergency. In such case, the FDA will communicate with the sponsor or applicant directly.

Coronavirus (COVID-19) Update: FDA Updates on Surveillance Inspections during COVID-19 (May 2020)

During COVID-19, the FDA will continue to utilize and implement additional alternative inspection tools and approaches while postponing domestic and foreign routine surveillance inspections. This will continue as local, national and international conditions warrant, with the exception of certain mission critical inspections identified on a case-by-case basis. The alternative approaches can include, among other things, evaluating records in lieu of conducting an onsite inspection on an interim basis when travel is not permissible.

COVID-19-Related Guidance Documents for Industry, FDA Staff, and Other Stakeholders (Updated: June 2020)

COVID-19 and Beyond: Oversight of the FDA’s Foreign Drug Manufacturing Inspection Process (June 2020)

Rare Disease Therapy Development and Access Remain Top FDA Priorities During COVID-19 (June 2020)

FDA Maintains the Pace of Meeting Its Goals on Applications for Medical Products During the Pandemic (June 2020)

Development and Licensure of Vaccines to Prevent COVID-19 (June 2020)

Coronavirus (COVID-19) Update: FDA Takes New Actions to Accelerate Development of Novel Prevention, Treatment Options for COVID-19 (May 2020)

Drug Development Inquiries for Drugs to Address the COVID-19 Public Health Emergency (May 2020)

Coronavirus Treatment Acceleration Program (CTAP) (April 2020)

Letter to Sponsors, Applicants and Regulated Entities on COVID-19 (April 2020)

EU/EMA

COVID-19: How EMA Fast-Tracks Development Support and Approval of Medicines and Vaccines (May 2020)

This press release summarizes the rapid procedures the EMA implemented to accelerate medicines and vaccines against COVID-19 regulatory pathway while assuring robustness of scientific opinions. Key procedures are outlined below:

• Accelerated support during research and development, including 1) rapid scientific advice; 2) rapid agreement of paediatric investigation plans (PIPs) and rapid compliance check
• Accelerated evaluation in authorization and post-authorization procedures, including: 1) Rolling review; 2) Accelerated assessment; 3) EMA further flexibility
• For a complete list and details, please refer to the inventory.

Notice to Stakeholders: Questions and Answers on Regulatory Expectations for Medicinal Products for Human Use During the COVID-19 Pandemic (April 2020)

This document provides guidance on regulatory expectations and flexibility to marketing authorization holders (MAHs) of medicinal products for human use during the COVID-19 pandemic. The document is being updated continuously, and the current key topics include:

• Issues related to marketing authorizations, and marketing authorization procedures
• Manufacturing, importation of finished products and active pharmaceutical ingredients; GMP and GDP issues
• Quality variations
• Product information and labelling
• Additional temporary GMP and GDP flexibility

Guidance for Medicine Developers and Companies on COVID-19 (Updated: June 2020)

EDQM Provides COVID-19 Vaccine Developers with Free Access to Quality Standards Applicable in Europe (June 2020)

First COVID-19 Treatment Recommended for EU Authorisation (June 2020)

EMA and Korean Ministry of Food and Drug Safety to Share Confidential COVID-19 Information (June 2020)

EMA Establishes Task Force to Take Quick and Coordinated Regulatory Action Related to COVID-19 Medicines (April 2020)

Update to Guidance on Regulatory Expectations in the Context of COVID-19 Pandemic (April 2020)

MHRA

MHRA Regulatory Flexibilities Resulting from Coronavirus (COVID-19) (Updated: June 2020)

MHRA Guidance on Coronavirus (COVID-19) (Updated: June 2020)

Exceptional GMP Flexibilities for Medicines Manufacturers during the Coronavirus (COVID-19) Outbreak (Updated: May 2020)

Guidance for Manufacturers and Good Practice (GxP) Laboratories on Exceptional Flexibilities for Maintenance and Calibration during the Coronavirus COVID-19 Outbreak (April 2020)

Approval of GxP Documents when Working from Home during the Coronavirus (COVID-19) Outbreak (April 2020)

New Arrangements for MHRA Good Practice (GxP) Inspections due to Coronavirus (COVID-19) (March 2020)

Exceptional GMP Flexibilities for Medicines Imported from Third Countries during the Coronavirus (COVID-19) Outbreak (March 2020)

Guidance for Good Laboratory Practice (GLP) Facilities in Relation to Coronavirus (COVID-19) (March 2020)

Health Canada

Applications for Drug Clinical Trials under the Interim Order: Guidance Document (May 2020)

Cross-Agency Collaboration

Global Regulators Work towards Alignment on Policy Approaches and Regulatory Flexibility during COVID-19 (June 2020)

Partnering with the European Union and Global Regulators on COVID-19 (June 2020)

FDA Holds Meetings with EC and EMA to Strengthen Medical Products Cooperation (June 2020)

NMPA

The NMPA guidance documents and updates are written in Chinese, therefore, we have provided more detailed summaries in English for your benefit. The WuXi Biologics Regulatory Affairs team may be available for consultation should your organization be actively pursuing drug development or entering clinical trials in China.

CMC Guidance for Medicine Developers and Companies on COVID-19 Neutralizing Antibody Development (May 2020)

The CDE released a CMC guidance to accelerate neutralizing antibody development and approval for COVID-19.

COVID-19 neutralizing antibody development may be accelerated based on knowledge gained from similar products manufactured with the same mature platform manufacturing technology as used for COVID-19 neutralizing antibody. Similarly, with appropriate justification, some aspects of manufacture and control may be based on the platform knowledge, and the need for product-specific data may be reduced. CDE recommends that manufacturers engage in early communications with CDE to discuss the type and extent of CMC information needed for the development and licensure of their COVID-19 neutralizing antibodies.

Click here to read  Q1 2020 Special Topic COVID-19 regulatory update