Pharma GMP News of the Week: 11-September-2022

Period: September 04, 2022 to September 10, 2022

PMDA Japan published English translation of guide to remote inspection procedure

Month news: August-September 2022

The Pharmaceuticals and Medical Devices Agency (PMDA) of Japan has translated its remote inspection method guide into English. The guide explains how businesses may prepare and distribute files for remote PMDA evaluation.

Source: https://www.pmda.go.jp/files/000247966.pdf 

MHRA published details of Fees payable to the MHRA for 2022 to 2023

Date of news: September 5, 2022

MHRA published details of Fees payable to the MHRA for 2022 to 2023 for the following on its website.

  1. Active pharmaceutical ingredients manufacturers and importers registration: fees
  2. Active substance importers or distributors: fees
  3. Active substance manufacturers: fees
  4. Blood banks: application fees for a Review Panel hearing
  5. Blood banks and other blood establishments: fees
  6. Blood facilities: contract laboratories fees
  7. Broker registration fees
  8. Clinical trials: application fees
  9. Clinical investigations for devices: fees
  10. Drug-device combination products: fees
  11. Homoeopathic National Rules Scheme: fees
  12. Homeopathic National Rules Scheme: fees for inspections
  13. Inspection: fees
  14. Licence applications: marketing authorisation fees
  15. Licence applications: manufacturers licence (including THMPD and homeopathic medicinal products)* fees
  16. Licence applications: parallel imports fees
  17. Licence applications: Phase 1 Accreditation Scheme fees
  18. Medicines export certificates: fees
  19. Periodic fees for holding a marketing authorisation
  20. Licence renewals, reclassifications and assessment of labels and leaflets: fees
  21. Orphan Marketing Products: fees
  22. Pharmacovigilance (PV) Safety Review: fees
  23. Plasma Master File (PMF) & Vaccine Antigen Master File certification or certified annual update work: fees
  24. Pre-Assessment (Rolling Review): fees
  25. Safety and quality vetting of unlicenced imported medicines fees
  26. Scientific advice meetings: fees
  27. Simplified Homeopathic Registration Scheme: fees
  28. Simplified Homeopathic Registration Scheme: Decentralised Procedure applications: fees
  29. Simplified Homoeopathic Registration Scheme: Mutual Recognition Procedures: fees
  30. Testing of samples: fees
  31. Traditional Herbal Registration Scheme: fees
  32. Variation: Homeopathic National Rules Scheme fees
  33. Variations: Homeopathic Simplified Scheme fees
  34. Variations: licence variations application fees
  35. Variations: licence variations applications groups fees
  36. Variations: other licence variations applications fees
  37. Variations: Traditional Herbal Registration Scheme fees
  38. Wholesale distribution authorisations: fees
  39. Fees: additional information

Source: https://www.gov.uk/government/publications/mhra-fees#full-publication-update-history 

WHO Expert Committee published guideline on Biological Standardization – WHO Technical Report Series – 1043

Date of news: September 5, 2022

This WHO guideline exclusively focused on 

Annex 1 – WHO Recommendations, Guidelines and other documents related to the manufacture, quality control and evaluation of biological products

Annex 2 – WHO manual for the preparation of reference materials for use as secondary standards in antibody testing.

Annex 3 – Guidelines on evaluation of biosimilars, Replacement of Annex 2 of WHO Technical Report Series, No. 977

Annex 4 – Guidelines for the production and quality control of monoclonal antibodies and related products intended for medicinal use Replacement of Annex 3 of WHO Technical Report Series, No. 822

Annex 5 – New and replacement WHO international reference standards for biological products.

Source: https://apps.who.int/iris/rest/bitstreams/1462954/retrieve 

News from EDQM – New FAQ on EDQM HelpDesk: Ph. Eur. revised general chapter 2.2.46. Chromatographic separation techniques

Date of news: September 8, 2022

Subsequent to the user inquiries via the EDQM HelpDesk, additional FAQs on the implementation of amended general chapter 2.2.46 have been published. Chromatographic separation techniques (11.0) have been added to the existing FAQs on European Pharmacopoeia and International Harmonization.

Source: https://www.edqm.eu/en/-/new-faq-on-edqm-helpdesk-ph.-eur.-revised-general-chapter-2.2.46.-chromatographic-separation-techniques-1 

FDA published draft guidance on “Statement of Identity and Strength — Content and Format of Labeling for Human Nonprescription Drug Products”

Date of news: September 8, 2022

The guideline recommends the structure and content of the mandatory statement of identity on human nonprescription pharmaceutical product labeling.

This document also includes recommendations for including the strength of the drug product on the labeling.

The suggestions in this guidance are designed to assist manufacturers, packers, distributors, sponsors and applicants, in ensuring that the statement of identity and strength for all human nonprescription medication products is uniform in content and structure.

Consistent content and structure of the declaration of identity and strength may help consumers compare nonprescription medicine goods and make appropriate self-selection decisions.

Source: https://www.fda.gov/media/161186/download 

FDA published draft guidance on “Quantitative Labeling of Sodium, Potassium, and Phosphorus for Human Over-the-Counter and Prescription Drug Products”

Date of news: September 8, 2022

This document contains guidelines for quantitative labeling of salt, potassium, and phosphorus in human prescription and over-the-counter (OTC) medications. 

This recommendation covers salt, potassium, and phosphorus as components of active or inactive pharmaceutical substances (e.g., sodium as a constituent of the inactive ingredient anhydrous trisodium citrate, phosphorus as a constituent of the inactive ingredient dibasic calcium phosphate, or sodium as a constituent of the active ingredient naproxen sodium). 

Orally consumed goods and injectable drugs containing 5 mg or more of salt, potassium, or elemental phosphorus per maximum single dose are included in the scope of this advisory. Individuals or institutions in charge of drug product labeling are advised to seek assistance from the FDA on specific instances.

Source: https://www.fda.gov/media/161194/download 

MHRA published “Summary of responses to consultation – new Code of Practice for the Expert Advisory Committees”

Date of news: September 8, 2022

Source: https://www.gov.uk/government/consultations/consultation-on-a-new-code-of-practice-for-the-expert-advisory-committees/outcome/summary-of-responses-to-consultation-new-code-of-practice-for-the-expert-advisory-committees 

MHRA Press release – Introduces new conflicts of interest code of practice for independent advisors

Date of news: September 8, 2022

The Medicines and Healthcare products Regulatory Agency (MHRA) is implementing a new, unified code of practise for all of its scientific advisory committees in order to ensure that the experts providing advice are independent and impartial, and that the processes in place to manage conflicts of interest are robust, consistent, and transparent to all.

The new code of practise is the result of a six-week public consultation, which was launched in response to a key recommendation of the Independent Medicines and Medical Devices Safety Review for the MHRA to review how it identifies and manages potential conflicts of interest from members of expert advisory committees. The Commission on Human Medicines (CHM) and its expert advisory committees are among them.

Source: https://www.gov.uk/government/news/mhra-launches-new-conflicts-of-interest-code-of-practice-for-independent-advisors 

FDA published final guidance on “Submitting Documents Using Real-World Data and Real-World Evidence to FDA for Drug and Biological Products”

Date of news: September 9, 2022

This recommendation encourages sponsors and applicants to indicate specific usage of RWD/RWE in their submission cover letters in order to facilitate FDA’s internal monitoring of submissions to the Agency that incorporate RWD/RWE. This recommendation does not impact FDA’s substantive examination of RWD/RWE submitted as part of the Agency’s routine review procedure.

This guidance applies to submissions for INDs, NDAs, and BLAs containing RWD/RWE intended to support a regulatory decision about product safety and/or efficacy.

Source: https://www.fda.gov/media/124795/download 

News from EDQM – Pharmacopoeial Discussion Group welcomes Indian Pharmacopoeia Commission to pilot for global expansion

Date of news: September 9, 2022

The PDG, which includes the European Pharmacopoeia (Ph. Eur. ), Japanese Pharmacopoeia (JP), and the United States Pharmacopoeia (USP), as well as the World Health Organization (WHO), welcome the Indian Pharmacopoeia Commission (IPC) as a participant in the PDG pilot for global expansion. This announcement follows the 2021 PDG Annual Meeting decision to launch a pilot for global membership expansion (“PDG prepares pilot for global membership expansion”), which was a critical first step in the PDG’s commitment to expanding the recognition of harmonised pharmacopoeial standards with the goal of achieving global convergence. The one-year expansion trial is set to begin with the PDG Annual Meeting, which will be held virtually in October 2022.

Source: https://www.edqm.eu/en/-/pdg-welcomes-indian-pharmacopoeia-commission-to-pilot-for-global-expansion

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