Pharmaceutical Guidelines Published in 2021

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.

 AgencyImportant updates for pharmaceuticals
EU6 Important Guidelines by EU in 2021
MHRASeveral guidelines and 11+ important blog post by MHRA in 2021
US-FDA12 Important Final Guidelines and 8 Draft Guidelines by US FDA in 2021
ICH8 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

Link: https://www.ema.europa.eu/en/documents/other/questions-answers-principles-gmp-manufacturing-starting-materials-biological-origin-used-transfer_en.pdf

2. EMA adopts guideline on quality documentation for drug-device combination products

Date of Guideline: July 22, 2021

Link: https://www.ema.europa.eu/en/documents/scientific-guideline/guideline-quality-documentation-medicinal-products-when-used-medical-device-first-version_en.pdf

3. EMA published Reflection paper on Good Manufacturing Practice and Marketing Authorisation Holders.

Date of Guideline: July 23, 2021

Link: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-good-manufacturing-practice-marketing-authorisation-holders_en-0.pdf

4. EMA published Reflection paper on statistical methodology for the comparative assessment of quality attributes in drug development

Date of Guideline: July 26, 2021

Link: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-statistical-methodology-comparative-assessment-quality-attributes-drug-development_en.pdf

5. EMA updated Q&A on nitrosamine assessment and testing

Date of Guideline: Oct 14, 2021

Link: https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-statistical-methodology-comparative-assessment-quality-attributes-drug-development_en.pdf

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 documentUpdate
Guidance on submitting clinical trial safety reports31 December 2020  
Registration of clinical trials for investigational medicinal products and publication of summary results31 December 2020  
Guidance on substantial amendments to a clinical trial31 December 2020

MHRA Guidelines on Devices

Name of documentUpdate
Guidance for retailers: supplying medical devices to Northern Ireland5 March 2021  
Regulating medical devices in the UK1 January 2022
Register medical devices to place on the market1 January 2022
Medical devices: conformity assessment and the UKCA mark31 December 2020

MHRA Guidelines on Importing and exporting

Name of documentUpdate
Importing medicines into Northern Ireland before 31 December 202122 December 2021
Supplying investigational medicinal products to Northern Ireland22 December 2021  
Supplying authorised medicines to Northern Ireland22 December 2021
Sourcing medicines for the UK Market22 December 2021
Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland22 December 2021
Importing investigational medicinal products into Great Britain from approved countries22 December 2021
List of approved countries for authorised human medicines22 December 2021  
Acting as a Responsible Person (import)  22 December 2021  

MHRA Guidelines on IT systems

Name of documentUpdate
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 documentUpdate
EU guidance documents referred to in the Human Medicines Regulations 201230 December 2020

MHRA Guidelines on Licensing

Name of documentUpdate
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 procedures23 August 2021
Decentralised and mutual recognition reliance procedure for marketing authorisations23 February 2021
Unfettered Access Procedure for marketing authorisations approved in Northern Ireland23 February 2021
European Commission (EC) Decision Reliance Procedure23 February 2021
150-day assessment for national applications for medicines31 December 2020
Rolling review for marketing authorisation applications31 December 2020
Guidance on handling of Decentralised and Mutual Recognition Procedures which are approved or pending22 December 2021
Procedural advice for Northern Ireland on applications for European Commission Centralised Marketing Authorisations31 December 2020
Guidance on MAH and QPPV location22 December 2021
Variations to Marketing Authorisations (MAs)31 December 2020
Conversion of Community Marketing Authorisations (CAPs) to Great Britain Marketing Authorisations (MAs) – letter to industry26 October 2020
Orphan medicinal products22 February 2021
Registering new packaging information for medicines31 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 handled31 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 Suitability31 December 2020
Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice31 December 2020
Reference Medicinal Products (RMPs)31 December 2020
Converting Centrally Authorised Products (CAPs) to UK Marketing Authorisations (MAs), ‘grandfathering’ and managing lifecycle changes15 October 2021  
Renewing Marketing Authorisations for medicines15 July 2021
Guidance on new provisions for traditional herbal medicinal products and homeopathic medicinal products31 December 2020
Guidance on licensing biosimilars, ATMPs and PMFs10 May 2021
Comparator products in Bioequivalence/Therapeutic Equivalence studies31 December 2020

MHRA Guidelines on Pharmacovigilance

Name of documentUpdate
Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA31 December 2020  
Guidance on pharmacovigilance procedures14 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 documentUpdate
Procedures for UK Paediatric Investigation Plan (PIPs)31 December 2020  
Completed Paediatric Studies – submission, processing and assessment31 December 2020  
Format and content of applications for agreement or modification of a Paediatric Investigation Plan31 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

Link: https://mhrainspectorate.blog.gov.uk/2021/01/29/pharmacovigilance-requirements-for-uk-authorised-products-13-january-2021/

3. Reference Safety Information (RSI) for Clinical Trials- Part III

Date of Publication: February 5, 2021

Link: https://mhrainspectorate.blog.gov.uk/2021/02/05/reference-safety-information-rsi-for-clinical-trials-part-iii/

4. Guidance on pharmacovigilance requirements for UK authorised products from 1 January 2021

Date of Publication: February 12, 2021

Link: https://mhrainspectorate.blog.gov.uk/2021/02/12/guidance-on-pharmacovigilance-requirements-for-uk-authorised-products-from-1-january-2021/

5. Pharmacovigilance inspection metrics April 2019 to March 2020

Date of Publication: February 26, 2021

Link: https://mhrainspectorate.blog.gov.uk/2021/02/26/pharmacovigilance-inspection-metrics-april-2019-to-march-2020/

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 

Link: https://mhrainspectorate.blog.gov.uk/2021/07/26/too-good-to-be-true-how-to-play-your-part-in-protecting-the-uk-medicines-supply-chain/

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 

Link: https://mhrainspectorate.blog.gov.uk/2021/08/20/get-involved-and-tell-us-your-pharmacovigilance-hot-topics/

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

Link: https://mhrainspectorate.blog.gov.uk/2021/09/27/updated-data-integrity-requirements-for-glp-monitoring-programme-members/

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

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/oral-drug-products-administered-enteral-feeding-tube-in-vitro-testing-and-labeling-recommendations

2. Questions and Answers on Quality Related Controlled Correspondence Guidance for Industry

Date of Guideline: September 20, 2021

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/questions-and-answers-quality-related-controlled-correspondence-guidance-industry

3. Microbiological Quality Considerations in Non-Sterile Drug Manufacturing

Date of Guideline: September 29, 2021

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/microbiological-quality-considerations-non-sterile-drug-manufacturing

4. Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices

Date of Guideline: September 29, 2021

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/investigator-responsibilities-safety-reporting-investigational-drugs-and-devices

5. Cover Letter Attachments for Controlled Correspondences and ANDA Submissions Guidance for Industry

Date of Guideline: December 10, 2021

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cover-letter-attachments-controlled-correspondences-and-anda-submissions-guidance-industry

6. Inspection of Injectable Products for Visible Particulates

Date of Guideline: December 16, 2021

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/inspection-injectable-products-visible-particulates

7. Definitions of Suspect Product and Illegitimate Product for Verification Obligations Under the Drug Supply Chain Security Act

Date of Guideline: June 03, 2021

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/definitions-suspect-product-and-illegitimate-product-verification-obligations-under-drug-supply

8. Enhanced Drug Distribution Security at the Package Level under the Drug Supply Chain Security Act

Date of Guideline: June 03, 2021

Link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/enhanced-drug-distribution-security-package-level-under-drug-supply-chain-security-act

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

Link: https://database.ich.org/sites/default/files/ICH_M7R2_Guideline-Addendum_Step2_ForPublicConsultation_2021_1006_1.pdf

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

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