Reflection on 2021: Guidance and important news published by different regulatory agencies and organizations for Pharmaceuticals in the year 2021
In the year 2021, regulatory bodies have published many important guidance to help pharmaceutical industry. In the article, compiled list of guidance published by EU, MHRA, US FDA, and ICH have been provided with relevant links that will take you to the reference source.
| Agency | Important updates for pharmaceuticals |
| EU | 6 Important Guidelines by EU in 2021 |
| MHRA | Several guidelines and 11+ important blog post by MHRA in 2021 |
| US-FDA | 12 Important Final Guidelines and 8 Draft Guidelines by US FDA in 2021 |
| ICH | 8 Important updates by ICH in 2021 |
EU: 6 Important Guidelines by EU in 2021
1. The EMA published a question-and-answer guidance on to address how GMP applied to starting materials for advanced therapy medicinal products of biological origin.
Date of Guideline: February 24, 2021
2. EMA adopts guideline on quality documentation for drug-device combination products
Date of Guideline: July 22, 2021
3. EMA published Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders.
Date of Guideline: July 23, 2021
4. EMA published Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development
Date of Guideline: July 26, 2021
5. EMA updated Q&A on nitrosamine assessment and testing
Date of Guideline: Oct 14, 2021
6. New MDCG guidance: Guidance on classification of medical devices
Date of Guideline: Oct 2021
Link: https://ec.europa.eu/health/sites/default/files/md_sector/docs/mdcg_2021-24_en.pdf
MHRA: Several guidelines and 11+ important blog post by MHRA in 2021
1. New guidance and information for industry from the MHRA – Guidance for industry and organisations to follow from 1 January 2021
MHRA Guidelines on Clinical trials
| Name of document | Update |
| Guidance on submitting clinical trial safety reports | 31 December 2020 |
| Registration of clinical trials for investigational medicinal products and publication of summary results | 31 December 2020 |
| Guidance on substantial amendments to a clinical trial | 31 December 2020 |
MHRA Guidelines on Devices
| Name of document | Update |
| Guidance for retailers: supplying medical devices to Northern Ireland | 5 March 2021 |
| Regulating medical devices in the UK | 1 January 2022 |
| Register medical devices to place on the market | 1 January 2022 |
| Medical devices: conformity assessment and the UKCA mark | 31 December 2020 |
MHRA Guidelines on Importing and exporting
| Name of document | Update |
| Importing medicines into Northern Ireland before 31 December 2021 | 22 December 2021 |
| Supplying investigational medicinal products to Northern Ireland | 22 December 2021 |
| Supplying authorised medicines to Northern Ireland | 22 December 2021 |
| Sourcing medicines for the UK Market | 22 December 2021 |
| Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland | 22 December 2021 |
| Importing investigational medicinal products into Great Britain from approved countries | 22 December 2021 |
| List of approved countries for authorised human medicines | 22 December 2021 |
| Acting as a Responsible Person (import) | 22 December 2021 |
MHRA Guidelines on IT systems
| Name of document | Update |
| Register to make submissions to the MHRA | 4 May 2021 |
| Webinars: information on how to make submissions to the MHRA | 31 December 2020 |
MHRA Guidelines on Legislation
| Name of document | Update |
| EU guidance documents referred to in the Human Medicines Regulations 2012 | 30 December 2020 |
MHRA Guidelines on Licensing
| Name of document | Update |
| Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs) | 30 December 2021 Decision |
| Marketing Authorisation Application submission dates for 150-days national and European Commission decision reliance procedures | 23 August 2021 |
| Decentralised and mutual recognition reliance procedure for marketing authorisations | 23 February 2021 |
| Unfettered Access Procedure for marketing authorisations approved in Northern Ireland | 23 February 2021 |
| European Commission (EC) Decision Reliance Procedure | 23 February 2021 |
| 150-day assessment for national applications for medicines | 31 December 2020 |
| Rolling review for marketing authorisation applications | 31 December 2020 |
| Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending | 22 December 2021 |
| Procedural advice for Northern Ireland on applications for European Commission Centralised Marketing Authorisations | 31 December 2020 |
| Guidance on MAH and QPPV location | 22 December 2021 |
| Variations to Marketing Authorisations (MAs) | 31 December 2020 |
| Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing Authorisations (MAs) – letter to industry | 26 October 2020 |
| Orphan medicinal products | 22 February 2021 |
| Registering new packaging information for medicines | 31 December 2020 |
| Guidance on the handling of applications for Centrally Authorised Products (CAPs) | 31 December 2020 |
| How Marketing Authorisation Applications referred under Article 29 are handled | 31 December 2020 |
| Converting Parallel Distribution Notices (PDNs) to UK Parallel Import Licences (PILs) | 31 December 2020 |
| Handling of Active Substance Master Files and Certificates of Suitability | 31 December 2020 |
| Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice | 31 December 2020 |
| Reference Medicinal Products (RMPs) | 31 December 2020 |
| Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), ‘grandfathering’ and managing lifecycle changes | 15 October 2021 |
| Renewing Marketing Authorisations for medicines | 15 July 2021 |
| Guidance on new provisions for traditional herbal medicinal products and homeopathic medicinal products | 31 December 2020 |
| Guidance on licensing biosimilars, ATMPs and PMFs | 10 May 2021 |
| Comparator products in Bioequivalence/Therapeutic Equivalence studies | 31 December 2020 |
MHRA Guidelines on Pharmacovigilance
| Name of document | Update |
| Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA | 31 December 2020 |
| Guidance on pharmacovigilance procedures | 14 October 2021 |
| Guidance on qualified person responsible for pharmacovigilance (QPPV) including pharmacovigilance system master files (PSMF) | 30 November 2021 |
MHRA Guidelines on Paediatrics
| Name of document | Update |
| Procedures for UK Paediatric Investigation Plan (PIPs) | 31 December 2020 |
| Completed Paediatric Studies – submission, processing and assessment | 31 December 2020 |
| Format and content of applications for agreement or modification of a Paediatric Investigation Plan | 31 December 2020 |
Link of all the guidelines: https://www.gov.uk/government/collections/new-guidance-and-information-for-industry-from-the-mhra
2. Pharmacovigilance requirements for UK authorised products: This webinar was part of a series of Brexit and post-transition guidance webinars
Date of Publication: January 13, 2021
3. Reference Safety Information (RSI) for Clinical Trials- Part III
Date of Publication: February 5, 2021
4. Guidance on pharmacovigilance requirements for UK authorised products from 1 January 2021
Date of Publication: February 12, 2021
5. Pharmacovigilance inspection metrics April 2019 to March 2020
Date of Publication: February 26, 2021
6. Inspectors grounded – a year of innovation
Date of Publication: March 26, 2021
Link: https://mhrainspectorate.blog.gov.uk/2021/03/26/inspectors-grounded-a-year-of-innovation/
7. Too good to be true? How to play your part in protecting the UK medicines supply chain (updated)
Date of Publication: July 26, 2021
8. Transfer of analytical methods
Date of Publication: August 13, 2021
Link: https://mhrainspectorate.blog.gov.uk/2021/08/13/transfer-of-analytical-methods/
9. Get involved and tell us your pharmacovigilance hot topics
Date of Publication: August 20, 2021
10. MHRA and US FDA tackle challenging data integrity
Date of Publication: September 1, 2021
Link: https://mhrainspectorate.blog.gov.uk/2021/09/01/mhra-and-us-fda-tackle-challenging-data-integrity/
11. Updated data integrity requirements for GLP Monitoring Programme members
Date of Publication: September 27, 2021
12. Supply Chain webinar: recording now available
Date of Publication: 30 September 2021 –
Link: https://mhrainspectorate.blog.gov.uk/2021/09/30/supply-chain-webinar-recording-now-available/
US FDA: 12 Important Final Guidelines US FDA in 2021
1. COVID-19: Container Closure System and Component Changes: Glass Vials and Stoppers
Date of Guideline: March 04, 2021
Link: https://www.fda.gov/media/146428/download
2. Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry
Date of Guideline: April 05, 2021
Link: https://www.fda.gov/media/147355/download
3. Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency Guidance for Industry
Date of Guideline: April 14, 2021
Link: https://www.fda.gov/media/147582/download
4. Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers
Date of Guideline: Previous version published in month of August 2020 and updated on May 17, 2021
Link: https://www.fda.gov/media/141312/download
5. Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
Date of Guideline: June 03, 2021
Link: https://www.fda.gov/media/88790/download
6. Product Identifiers under the Drug Supply Chain Security Act (DSCSA) – Questions and Answers
Date of Guideline: June 03, 2021
Link: https://www.fda.gov/media/116304/download
7. Providing Regulatory Submissions in Alternate Electronic Format Guidance for Industry
Date of Guideline: July 01, 2021
Link: https://www.fda.gov/media/135951/download
8. Field Alert Report Submission: Questions and Answers Guidance for Industry
Date of Guideline: July 22, 2021
Link: https://www.fda.gov/media/114549/download
9. Development and Submission of Near Infrared Analytical Procedures
Date of Guideline: August 06, 2021
Link: https://www.fda.gov/media/91343/download
10. Development of Abbreviated New Drug Applications During the COVID-19 Pandemic – Questions and Answers Guidance for Industry
Date of Guideline: September 08, 2021
Link: https://www.fda.gov/media/147355/download
11. Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers
Date of Guideline: September 30, 2021
Link: https://www.fda.gov/media/133619/download
12. CMC Postapproval Manufacturing Changes for Specified Biological Products To Be Documented in Annual Reports
Date of Guideline: December 09, 2021
Link: https://www.fda.gov/media/106935/download
US FDA: 8 Important Draft Guidelines by US FDA in 2021
1. Oral Drug Products Administered Via Enteral Feeding Tube: In Vitro Testing and Labeling Recommendations Guidance for Industry
Date of Guideline: June 02, 2021
2. Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry
Date of Guideline: September 20, 2021
3. Microbiological Quality Considerations in Non-Sterile Drug Manufacturing
Date of Guideline: September 29, 2021
4. Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices
Date of Guideline: September 29, 2021
5. Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry
Date of Guideline: December 10, 2021
6. Inspection of Injectable Products for Visible Particulates
Date of Guideline: December 16, 2021
7. Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act
Date of Guideline: June 03, 2021
8. Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act
Date of Guideline: June 03, 2021
ICH: 8 Important updates by ICH in 2021
1. Draft Principles of ICH E6 Good Clinical Practice (GCP) now available
ICH E6: Good Clinical Practice (GCP) Guideline
Date of Publication: April 19, 2021
Link: https://database.ich.org/sites/default/files/ICH_E6-R3_GCP-Principles_Draft_2021_0419.pdf
2. The ICH Q3C(R8) Guideline reaches Step 4 of the ICH Process
Q3C(R8): Guideline for Residual Solvents
Date of Publication: April 23, 2021
Link: https://database.ich.org/sites/default/files/ICH_Q3C-R8_Guideline_Step4_2021_0422_1.pdf
3. The ICH S1B(R1) draft Guideline reaches Step 2 of the ICH process
S1B: Testing for Carcinogenicity of Pharmaceuticals
Date of Publication: May 10, 2021
Link: https://database.ich.org/sites/default/files/ICH_S1BR1_Step2_DraftGuideline_2021_0510.pdf
4. The ICH S12 Step 2 presentation available now on the ICH website
S12: Nonclinical Biodistribution Considerations for Gene Therapy Products
Date of Publication: June 23, 2021
Link: https://database.ich.org/sites/default/files/S12_Step2_Presentation_2021_0618_0.pdf
5. Information Paper regarding the Use of ISO IDMP Standards in ICH E2B(R3) Messages
E2B(R3): Clinical Safety Data Management: Data Elements for Transmission of Individual Case Safety Reports (ICSRs)
Date of Publication: June 25, 2021
Link: https://www.ich.org/page/e2br3-individual-case-safety-report-icsr-specification-and-related-files
6. The ICH Q13 draft Guideline reaches Step 2 of the ICH process
Q13: Continuous manufacturing of drug substances and drug products
Date of Publication: July 27, 2021
Link: https://database.ich.org/sites/default/files/ICH_Q13_Step2_DraftGuideline_%202021_0727.pdf
7. The ICH M7(R2) draft Guideline and Addendum reaches Step 2 of the ICH process
M7(R2): Application of the principles of the ICH M7 guideline to calculation of compound-specific acceptable intakes
Date of Publication: October 6, 2021
8. The ICH E8(R1) Guideline reaches Step 4 of the ICH Process
E8(R1): General considerations for clinical studies
Date of Publication: October 6, 2021
Link: https://database.ich.org/sites/default/files/E8-R1_Guideline_Step4_2021_1006.pdf