Guidelines for Human and Veterinary Medicinal Products - Worldwide Developments
This article was originally published in SRA
Executive Summary
Recently updated and newly issued documents.
1. Human Medicinal Products
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Clinical Investigation
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Note for Guidance on Evaluation of Anticancer Medicinal Products in Man
EMEA, CPMP/EWP/205/95 rev 2 - corr, 19 September 2002
Australia
Final
Effective 15 September 2005
This is the adoption of the identical European guideline.
Guidance for Industry: Collection of Race and Ethnicity Data in Clinical Trials
FDA, Federal Register, 19 September 2005, 70(180), 54946-54947
US
Final
Submit comments at any time
This guidance is intended to assist sponsors in the collection of race and ethnicity information in clinical trials conducted in the US and abroad for certain Food and Drug Administration-regulated products and using a standardised approach. See Worldwide Update for more details.
Draft Clinical Evaluation Guidance for Drugs for the Treatment of an Overactive Bladder
Ministry of Health, Labour and Welfare
Japan
Draft
Submit comments by 31 August 2005
These draft guidelines cover the clinical evaluation of drugs for the treatment of an overactive bladder.
Guidance for Industry: Gene Therapy Clinical Trials - Observing Participants for Delayed Adverse Events
FDA, Federal Register, 23 August 2005, 70(162), 49296-49297
US
Draft
Submit comments by 21 November 2005
This draft guidance provides recommendations to sponsors of gene therapy studies on: 1) methods to assess the risk of delayed adverse events following gene therapy exposure; 2) guidance for determining the likelihood that long-term follow-up studies on participants will provide scientifically meaningful information; and 3) specific advice regarding the duration and design of long-term follow-up observations. See Worldwide Update for more details.
Packaging and Labelling
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Guideline on Plastic Immediate Packaging Materials
EMEA, CPMP/QWP/4359/03, CVMP/205/04, 19 May 2005
Australia
Final
Effective 1 December 2005
This is the adoption of the identical European guideline.
Procedural
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Federal Guidelines for Requesting, Stockpiling and Distributing Potassium Iodide (KI) from the Strategic National Stockpile (SNS)
FDA, Federal Register, 29 August 2005, 70(166), 51065-51069
US
Final
Submit comments by 1 November 2005
This document contains guidelines for state, local and tribal (native American) governments for the expanded distribution, stockpiling and utilisation of potassium iodide (KI) in the event of a radiocactive iodine release from a commercial nuclear power plant incident. The programme would extend coverage from the current ten mile radius up to twenty miles from a commercial nuclear power plant. These guidelines have been issued in accordance with section 127 of the Bioterrorism Act of 2002.
Draft Guidance for Industry on the Pediatric Research Equity Act
FDA, Federal Register, 7 September 2005, 70(172), 53233-53235
US
Draft
Submit comments by 7 November 2005
This draft guidance provides recommendations on how to interpret the requirements of the Pediatric Research Equity Act (PREA). PREA requires new drug applications (NDAs) and biologics licensing applications (BLAs) (or supplements to an application) for a new active ingredient, new indication, new dosage form, new dosage regimen or new route of administration to contain a paediatric assessment unless the applicant has obtained a waiver or deferral. The draft guidance applies only to new applications or supplements to applications for drugs and biological products. It provides recommendations: for submitting paediatric studies; on how to make a request for a deferral of some or all assessments of safety and effectiveness required under PREA; on how to request a full or partial waiver of the paediatric study requirements; and for applicants to meet with the FDA to discuss plans and timelines for paediatric studies and any planned requests for deferrals or waivers. It also discusses when sponsors may need to report on the status of postmarketing commitments.
International Conference on Harmonisation: Draft Guidance on M5 Data Elements and Standards for Drug Dictionaries
FDA, Federal Register, 6 September 2005, 70(171), 53021-53022
US
Draft
Submit comments by 21 October 2005
This draft guidance describes the data elements that the International Conference on Harmonisation recommends be made available to interested parties to assist in the development and maintenance of drug dictionaries. The guidance refers to approved medicinal products only. Its goals include: to improve the exchange of medicinal product information at the international level; to improve consistency in evaluating and comparing medicinal products for postmarketing surveillance activities; to provide consistent terminology for the healthcare community; and to reduce administrative burdens for the pharmaceutical industry when complying with different regional regulatory requirements.
Draft Operational Procedure on Handling of “Consultation with Target Patient Groups” on Package Leaflets (PL) for Centrally Authorised Products for Human Use
EMEA, EMEA/277378/2005, 7 September 2005
EU
Draft
This document addresses some practical and operational issues to guide applicants and market authorisation holders on how to handle consultations with target patient groups. Under the new medicines legislation (Directive 2001/83, as amended), package leaflets must reflect the results of consultations with target patient groups to ensure that they are legible, clear and easy to use. The results of assessments carried out with the cooperation of such groups must also be provided to the competent authority. The guidance applies to centralised procedure applications for new medicinal products for human use as of 20 November 2005.
Guideline on Risk Management Systems for Medicinal Products for Human Use
EMEA, EMEA/CHMP/96268/2005, 6 September 2005
EU
Draft
Submit comments by 5 October 2005
This draft document provides guidance for marketing authorisation holders and applicants to meet the requirements for a risk management system that they will introduce for an individual medicinal product or a series of medicinal products. This is in keeping with the introduction of the new European medicines legislation. It also describes how a risk management system can be presented to competent authorities in the form of a risk management plan.
Guideline on the Processing of Renewals in the Mutual Recognition and Decentralised Procedures
Mutual Recognition Facilitation Group, 31 August 2005
EU
Draft
This guideline has been updated to reflect the adoption of new pharmaceutical legislation in accordance with Directive 2001/83/EC, as amended. It considers issues associated with the processing of renewals with the aim of giving procedural advice in order to ensure a consistent and beneficial approach to renewal. It provides a renewal timetable and a checklist of all the relevant documentation that is required during a submission. Member states have until 30 October 2005 to update their laws and regulations to comply with the amended directive.
Product Development
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Draft Guidance for Industry on Gingivitis: Development and Evaluation of Drugs for Treatment or Prevention
FDA, Federal Register, 24 August 2005, 70(163), 49660-49661
US
Draft
Submit comments by 28 October 2005
The FDA is extending to 28 October 2005 the comment period for this draft, which addresses specific protocol design elements as well as general concerns to help sponsors develop clinical trials for drug products that treat or prevent gingivitis. The original comment period ended on 29 August 2005.
Draft Guidance for Industry on Acne Vulgaris: Developing Drugs for Treatment
FDA, Federal Register, 19 September 2005, 70(180), 54945-54946
US
Draft
Submit comments by 19 December 2005
Guidance is given on the development of drugs for the treatment of acne vulgaris other than nodulocystic acne. It will help applicants to plan clinical studies, design clinical protocols, implement and monitor the conduct of clinical trials, collect relevant data for analysis and perform appropriate types of analyses of study data.
Product-specific Guidelines
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Australian Regulatory Guidelines for Complementary Medicines (ARGCM): Part IV - General Guidance
Therapeutic Goods Administration, September 2005
Australia
Final
Part IV of the guidelines provides general guidance in relation to complementary medicine modalities such as homoeopathy, traditional herbal medicines and aromatherapy. This part also provides information on exempt medicines, combination complementary/pharmaceutical medicines and the food/medicine interface, Australian native and endangered species in therapeutic goods and genetically modified organisms.
Quality (Chemistry, Manufacturing and Control)
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Draft Guidance for Industry on Abbreviated New Drug Applications: Impurities in Drug Products; Chemistry, Manufacturing and Controls Information
FDA, Federal Register, 29 August 2005, 70(166), 51077
US
Draft
Submit comments by 28 November 2005
This document revises draft guidance issued on January 1999. It provides updated information on the listing of degradation products, setting acceptance criteria and qualifying degradation products in conformance with the FDA's current thinking and the revision of the International Conference on Harmonisation guidance for industry, Q3B(R) Impurities in New Drug Products, published in November 2003.
Safety
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Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products
EMEA, EMEA/410/01 REV2, 28 January 2004
Australia
Final
Effective 21 September 2005
This EU guideline has been adopted in Australia by the Therapeutic Goods Administration with the following notation: ‘This guideline replaces EMEA/410/01 REV 1 (adopted by the TGA on 20 December 2002). This EU guideline should be interpreted in the context of the TGA Policy Document - Supplementary Requirements for Therapeutic Goods for Minimising the Risk of Transmitting Transmissible Spongiform Encephalopathies (TSEs).’
2. Veterinary Medicinal Products
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Packaging and Labelling
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Guideline on Plastic Immediate Packaging Materials
EMEA, CPMP/QWP/4359/03, CVMP/205/04, 19 May 2005
Australia
Final
Effective 1 December 2005
See human medicinal guidelines section.
Safety
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Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products
EMEA, EMEA/410/01 REV2, 28 January 2004
Australia
Final
Effective 21 September 2005
See human medicinal guidelines section.
Sources
Guidance documents are accessible at the following websites:
Australia - www.tga.gov.au and www.apvma.gov.au; Japan - www.mhlw.go.jp; EU - www.emea.eu.int; and USA - www.fda.gov.