Pharma GMP News of the Week: 9-January-2022
Period: January 02, 2022 to January 08, 2022
New European Pharmacopoeia texts and that have undergone technical revisions are published for comments.
Date of news: January 05, 2022
Total 48 drafts monographs published for comments on Pharmeuropa 34.1 and deadline for the comments is 31 March 2022.
Source: https://www.edqm.eu/en/news/pharmeuropa-341-just-released
ICH published brief overview ICH’s mission, structure and current work
Date of publication: January 05, 2022
ICH released a Leaflet on ICH’s mission, structure and current work.
Source: https://admin.ich.org/sites/default/files/inline-files/ICH_leaflet_2021_1221.pdf
MHRA updated guidance for regulating medical devices in the UK
Date of publication: January 01, 2022
The purpose of the guidance updated was to reflect changes to medical device regulatory requirements that will take effect from January 1, 2022. It covers what one should do to deploy a medical device in the Great Britain, European Union (EU) markets, and Northern Ireland.
Source: https://www.gov.uk/guidance/regulating-medical-devices-in-the-uk
MHRA published official Statistics regarding expected time taken to process and grant a marketing authorisation or a variation to a marketing authorisation.
Date of publication: January 04, 2022
Source: https://www.gov.uk/government/statistics/medicines-licensing-time-based-performance-measures
MHRA updated various documents and guidance from January 1, 2022 to January 7, 2022
Date of updates: January 1, 2022 to January 7, 2022
- Great Britain Marketing Authorisations (MAs) for Centrally Authorised Products (CAPs)
- Clinical trials for medicines: apply for authorisation in the UK
- Apply for the early access to medicines scheme (EAMS)
- Innovative Licensing and Access Pathway
- Coronavirus (COVID-19) vaccines adverse reactions
- Suspended and revoked licences and registrations for manufacturers and wholesalers of medicines and ingredients
- Importing medicines into Northern Ireland
- Regulatory approval of Vaxzevria (previously COVID-19 Vaccine AstraZeneca)
- Notify the MHRA about a clinical investigation for a medical device
- Medicines: licensing time-based performance measures
- Human and veterinary medicines: register of licensed wholesale distribution sites
- Medicines: new manufacturing and wholesale dealer licences
- Register of brokers authorised to deal in human medicines
- Medicines: terminated and cancelled manufacturing and wholesale dealer licences
- Regulating medical devices in the UK
- Register medical devices to place on the market
Source: https://www.gov.uk
The eur-lex.europa.eu on January 04, 2021 officially acknowledged harmonized standards for medical devices that device manufacturers can use in order to comply requirements under the Medical Devices Regulation (MDR).
Date of publication: January 04, 2021
This includes:
Sterilization
Biological evaluation of medical devices
Aseptic processing
Use of symbols in product information
Quality management systems
According to the European Commission, “devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.”
Commission Implementing Decision (EU) 2021/1182 dated 16 July 2021
| Sr. No. | EN ISO Standard | Description of standard |
| 1. | EN ISO 25424:2019 | Sterilization of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 25424:2018) |
| 2. | EN ISO 11137-1:2015 | Sterilization of health care products – Radiation – Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd 1:2013) |
| 3. | EN ISO 11135:2014 | Sterilization of health care products – Ethylene oxide – Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 11135:2014) |
| 4. | EN ISO 11737-2:2020 | Sterilization of health care products – Microbiological methods – Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process (ISO 11737-2:2019) |
| 5. | EN ISO 10993-23:2021 | Biological evaluation of medical devices – Part 23: Tests for irritation (ISO 10993-23:2021) |
Commission Implementing Decision (EU) 2022/6 dated 4 January 2022
| Sr. No. | EN ISO Standard | Description of standard |
| 6. | EN ISO 10993-12:2021 | Biological evaluation of medical devices – Part 12: Sample preparation and reference materials (ISO 10993-12:2021) |
| 7. | EN ISO 10993-9:2021 | Biological evaluation of medical devices – Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) |
| 8. | EN ISO 13408-6:2021 | Aseptic processing of health care products – Part 6: Isolator systems (ISO 13408-6:2021) |
| 9. | EN ISO 11737-1:2018 | Sterilization of health care products – Microbiological methods – Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2018) |
| 10. | EN ISO 14160:2021 | Sterilization of health care products – Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives – Requirements for characterization, development, validation and routine control of a sterilization process for medical devices (ISO 14160:2020) |
| 11. | EN ISO 13485:2016 | Medical devices – Quality management systems – Requirements for regulatory purposes (ISO 13485:2016) |
| 12. | EN ISO 17664-1:2021 | Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1: Critical and semi-critical medical devices (ISO 17664-1:2021) |
| 13. | EN ISO 15223-1:2021 | Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements (ISO 15223-1:2021) |
| 14. | EN IEC 60601-2-83:2020 | Medical electrical equipment – Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment |
Source:
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021D1182&from=EN
https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32022D0006&from=EN
FDA mission-critical work certain – inspectional activities has temporarily postponed
Date of press-announcements: January 4, 2022
According to press-announcements, “On Dec. 29, the FDA implemented temporary changes to its inspectional activities to ensure the safety of its employees and those of the firms it regulates as the agency further adapts to the evolving COVID-19 pandemic and the spread of the omicron variant. Through Jan.19, the agency intends to continue mission-critical work but has temporarily postponed certain inspectional activities with the hopes of restarting these activities as soon as possible”.
Source: https://www.fda.gov/news-events/press-announcements/fda-roundup-january-4-2022