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FDA- Recent Guidance Documents (Summary)
2021
M9 Biopharmaceutics Classification System-Based Biowaivers.
M9 Biopharmaceutics Classification System-Based Biowaivers | FDA
Issued by: Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research”
Summary: In May 2021, FDA posted the guidance for industry entitled “M9 biopharmaceutics classification system-based biowaivers,” a draft of which was issued in October 2018. The guidance provides recommendations to support the biopharmaceutics classification of drug substances and the biopharmaceutics classification system (BCS)-based waiver of the in vivo bioequivalence study requirement for drug products. To aid applicants, the FDA has also posted summary tables for ANDA submissions that contain BCS-based waiver requests pursuant to ICH Guideline M9: biopharmaceutics classification system-based biowaivers. This guidance supersedes the December 2017 FDA guidance for industry “Waiver of in vivo bioavailability and bioequivalence studies for immediate-release solid oral dosage forms based on a biopharmaceutics classification system.”
Q12 Technical and Regulatory considerations for Pharmaceutical Product lifecycle Management Guidance for Industry.
Issued by: Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research
Summary: In May 2021, FDA posted this document. This guidance provides a framework to facilitate the management of post approval chemistry, manufacturing, and controls (CMC) changes in a more predictable and efficient manner. A harmonized approach regarding technical and regulatory considerations for lifecycle management will benefit patients, industry, and regulatory authorities by promoting innovation and continual improvement in the pharmaceutical sector, strengthening quality assurance, and improving supply of medicinal products.
S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals Guidance for Industry
S5(R3) Detection of Reproductive and Developmental Toxicity for Human Pharmaceuticals | FDA
Issued by: Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research
Summary: In May 2021, FDA posted the guidance. The purpose of this guidance is to recommend international standards for, and promote harmonization of, the assessment of nonclinical developmental and reproductive toxicity (DART) testing necessary to support human clinical trials and marketing authorization for pharmaceuticals. The guidance describes potential strategies and study designs to supplement available data to identify, assess, and convey risk. General concepts and recommendations are also provided that should be considered when interpreting study data.
Q3D(R2) – Guideline for Elemental Impurities Draft International Council for Harmonization, Draft Guidance for Industry.
Q3D(R2) – Guideline for Elemental Impurities | FDA
Issued by: Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research
Summary: In May, 2021, the FDA posted this document. This document for is comprised of extracts of the Q3D(R2) Guideline with the revisions to the Q3D(R1) Guideline, Part 1 – extract of appendix 2: correction of PDEs for Gold, Silver and Nickel, Part 2 – extract of appendix 3: correction of Gold monograph, Part 3 – extract of appendix 3: correction of Silver monograph and Part 4 – new appendix 5.
E9(R1) Statistical Principles for Clinical Trials: Addendum: Estimands and sensitivity Analysis in Clinical Trials Guidance for Industry.
Issued by: Center for Biologics Evaluation and Research, Center for Drug Evaluation and Research
Summary: In May, 2021, the FDA posted this document. This addendum presents a structured framework to strengthen the dialogue between disciplines involved in the formulation of clinical trial objectives, design, conduct, analysis, and interpretation, as well as between sponsor and regulator regarding the treatment effect or effects of interest that a clinical trial should address.
April 2021, Development of Abbreviated New Drug Applications during the COVID-19 Pandemic –Questions and Answers Guidance for Industry
FDA published final guideline on April 5, 2021. FDA has received questions from prospective applicants and applicants of ANDAs about generic drug product development and application assessment during the COVID-19 public health emergency and is providing the responses in this guidance document for the benefit of all stakeholders. FDA intends to revise and update this guidance as appropriate to address new questions. The questions and answers are presented in the following categories: A) generic drug product development; B) submission and assessment of ANDAs; and C) marketing and exclusivity.
March 2021,COVID-19 Container Closure System and Component changes: Glass Vials and Stoppers Guidance for Industry
FDA published final guidance on March 4, 2021. 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 consisting of glass vials and stoppers for approved sterile drug products, including biological products, administered parenterally. This guidance also discusses pathways available to application holders to obtain agency feedback.
Jan 2021, IND Submissions for Individualized Antisense Oligonucleotide Drug Products: Administrative and Procedural Recommendations Guidance for Sponsor-Investigators
FDA published draft of this guidance on January 4, 2021. This guidance is intended for sponsor-investigators (hereafter referred to as sponsors) developing individualized investigational antisense oligonucleotide (ASO) drug products for a severely debilitating or life-threatening genetic disease.
Dec 2020, Providing Regulatory Submissions in Electronic format -Content of the Risk Evaluation and Mitigation strategies Document using Structured Product Labeling
FDA published final guidance on December 23, 2020. This guidance describes the format requirements for the electronic submission of the content of a risk evaluation and mitigation strategy (REMS) document under section 745A(a) of the FD&C Act. This guidance describes how FDA will implement the requirements for the electronic submission of REMS documents as part of submissions under new drug applications (NDAs), abbreviated new drug applications (ANDAs), and, as described in Section III below, certain biologics license applications (BLAs)
MHRA Latest Regulatory Updates (Summary)
May 2021, Guidance to make Submissions related to Human Medicines to the MHRA (Medicines and Healthcare Products Regulatory Agency)
Register to make submissions to the MHRA – GOV.UK (www.gov.uk)
Guidance to make submissions related to human medicines to the MHRA (Medicines and Healthcare products Regulatory Agency)
The guidance was initially published on December 31, 2020 and updated on May 4, 2021. Major contents of Guidance include two topics:
- Gaining Access to MHRA Submissions
- Registering to use the vigilance systems: MHRA Gateway and ICSR Submissions
Guidance includes three short video demos which cover all aspects of the user access management process – these steps will enable any organization to gain access and manage user permissions for using MHRA submissions. These videos are titled as:
- User registration – the end-to-end process for adding an initial company administrator.
- Add a new user – how to add an internal colleague as a user or company administrator.
- Add a new external user – how to add a third-party consultant/consultancy as a user or company administrator.
For applications that are needed to submit to the UK (for example, a Marketing Authorization for the UK or GB market) will be applied through our national portals. For those regulatory submissions which intended to made through European procedures, will need to continue to submit via the EU portals (for example, CESP).
The information on how to make submissions to the MHRA is for the following groups:
- All pharmaceutical companies involved in making medicines regulatory submissions and vigilance activities for UK/GB licenses.
- All medicines clinical trial sponsors wishing to make clinical trial submissions (Initial Applications, Substantial Amendments, End of Trial Notifications and Developmental Safety Update Reports (DSURs)) to the Agency
- e-cigarette producers
- Brokers of medicinal products
There are two user reference guides which contain step by step guidance on the processes which are Gaining access to MHRA Submissions & Managing users on MHRA Submissions.
Collection, ‘Licensing: How to Apply’.
Licencing: how to apply – GOV.UK (www.gov.uk)
MHRA published this collective information on May 4, 2021. This collection includes all the information regarding how to license a medicine for sale in the UK, including national and international routes, and information on fees. It comprises all the national routes to obtain a marketing authorization in the United Kingdom (UK), Great Britain (England, Scotland, and Wales) or Northern Ireland and international routes to market a medicine in the UK, Australia, Canada, Singapore and/or Switzerland. Project Orbis is a program coordinating the review and approval of promising cancer treatments. All the Applications must be submitted through the MHRA submissions portal.
March 2021,
Guidance for types of Application (Legal basis)
Types of application (legal basis) – GOV.UK (www.gov.uk)
New guidance published and updated in March 2021. It includes appropriate legal basis for application when one applies to MHRA for a marketing authorization. The legal bases included are full application (regulation 50), generic application (regulation 51, 51A & 51B), hybrid application (regulation 52, 52A & 52B) and similar biological application (regulation 53, 53A & 53B). It also contains regulation 54-56.
Guidance for Electronic Application Form and Cover Letter Tool.
Electronic Application Form and Cover Letter Tool – GOV.UK (www.gov.uk)
New guidance published in March 2021. It is a guidance on how to complete electronic application form (eAF) and cover letter. This tool is designed to help applicants determine the additional information required in the cover letters and eAFs of initial and variation applications. One should answer all the questions in the tool fully to make sure that all the information required for application is correct. Failure to submit the appropriate information in the cover letter and the dossier may result in the application being invalidated.
Guidance for Innovative Licensing and Access Pathway
Innovative Licensing and Access Pathway – GOV.UK (www.gov.uk)
New guidance published in March 2021. The Innovative Licensing and Access Pathway (ILAP) aims to accelerate the time to market, facilitating patient access to medicines. These medicines include new chemical entities, biological medicines, new indications, and repurposed medicines. It comprises of an innovation passport designation, a target development profile (TDP) and provides applicants with access to a toolkit to support all stages of the design, development, and approvals process.
Guidance for Good Laboratory Practice (GLP) for Safety Tests on Chemicals.
Good laboratory practice (GLP) for safety tests on chemicals – GOV.UK (www.gov.uk)
The guidance was published in 2014 and recently updated in March 2021. The updated version includes information on new arrangements for inspections during the coronavirus (COVID-19) outbreak and guidance for good laboratory practice (GLP) facilities in relation to coronavirus (COVID-19). According to guideline, due to outbreak of COVID-19, only essential on-site good practice (GxP) inspections of laboratories, clinical trials, manufacturing, distribution, and pharmacovigilance until further notice.
Responding to a GLP and GCP Laboratory Inspection Report.
Responding to a GLP and GCP laboratory inspection report – GOV.UK (www.gov.uk)
New guidance published in March 2021. It is guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) inspection reports. It includes definitions like critical deficiencies, major deficiencies, and other deficiencies. Information about completion of CAPA (corrective and preventive actions), next inspection and change notification is also included.
Guidance to Register Medical Devices to place on the Market.
Register medical devices to place on the market – GOV.UK (www.gov.uk)
The guidance was published in 2020 and recently updated in March 2021. It guides to register medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland. It includes information regarding who and when must register, information and fees required for registration. How to apply to register on the Device Online Registration System (DORS). Video guidance also included.
Guidance for Good Clinical Practice for Clinical Trials.
Good clinical practice for clinical trials – GOV.UK (www.gov.uk)
The guidance was published in 2014 and recently updated in March 2021. Good clinical practice (GCP) is a set of internationally recognized ethical and scientific quality requirements that must be followed when designing, conducting, recording, and reporting clinical trials that involve people. Guideline includes Inspections under the risk-based compliance programme, pre-inspection documentation, inspection plan, inspection findings, actions after the inspection and European and UK law for GCP.
Key Role of Regulatory Affairs
Maintain trail of constantly modifying Regulations.
Laws and regulations evolve within countries and harmonized at worldwide levels with the development of new health care techniques and globalization of pharmaceutical market. Different countries are bound to different regulatory bodies like U.S. FDA, EU, TGA, EMEA, Health Canada etc. It is responsibility of regulatory person to track down all the changes and requirements developed by these bodies for getting new products approved. Commitments which are necessary for approval of products should be established by Regulatory affairs.
Registration of documents to various Regulatory Bodies
Regulatory affairs interact with worldwide, federal, local regulatory agencies to assure licensing, registration, development, manufacturing, marketing, and labelling of drug substances and pharmaceutical products in compliance with all applicable rules. This entails preparation of organized and scientifically valid NDA, ANDA, INDA, MAA, DMF submissions in accordance with cGMP, ICH, GCP, GLP guidelines, regulations, and laws. Regulatory affairs are liable to protect public health, by controlling the safety and efficacy of products in areas including pharmaceuticals and medical devices.
Provide planned and specialized advice to R&D, Production , QC etc.
Presenting expertise and regulatory intelligence in translating regulatory requirements into practical workable plans is an integral part of regulatory affairs. The role opens from development of a product to producing, marketing and post marketing strategies. Legal and technical guidance at all stages help companies save a lot of time and money in developing the pharmaceutical products.
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