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.
- Active pharmaceutical ingredients manufacturers and importers registration: fees
- Active substance importers or distributors: fees
- Active substance manufacturers: fees
- Blood banks: application fees for a Review Panel hearing
- Blood banks and other blood establishments: fees
- Blood facilities: contract laboratories fees
- Broker registration fees
- Clinical trials: application fees
- Clinical investigations for devices: fees
- Drug-device combination products: fees
- Homoeopathic National Rules Scheme: fees
- Homeopathic National Rules Scheme: fees for inspections
- Inspection: fees
- Licence applications: marketing authorisation fees
- Licence applications: manufacturers licence (including THMPD and homeopathic medicinal products)* fees
- Licence applications: parallel imports fees
- Licence applications: Phase 1 Accreditation Scheme fees
- Medicines export certificates: fees
- Periodic fees for holding a marketing authorisation
- Licence renewals, reclassifications and assessment of labels and leaflets: fees
- Orphan Marketing Products: fees
- Pharmacovigilance (PV) Safety Review: fees
- Plasma Master File (PMF) & Vaccine Antigen Master File certification or certified annual update work: fees
- Pre-Assessment (Rolling Review): fees
- Safety and quality vetting of unlicenced imported medicines fees
- Scientific advice meetings: fees
- Simplified Homeopathic Registration Scheme: fees
- Simplified Homeopathic Registration Scheme: Decentralised Procedure applications: fees
- Simplified Homoeopathic Registration Scheme: Mutual Recognition Procedures: fees
- Testing of samples: fees
- Traditional Herbal Registration Scheme: fees
- Variation: Homeopathic National Rules Scheme fees
- Variations: Homeopathic Simplified Scheme fees
- Variations: licence variations application fees
- Variations: licence variations applications groups fees
- Variations: other licence variations applications fees
- Variations: Traditional Herbal Registration Scheme fees
- Wholesale distribution authorisations: fees
- 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.
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
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.
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