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Guidance's
MHRA:
- MHRA guidance on new Medical Devices Post-Market Surveillance requirements
- Renewing marketing authorisations for medicines
- Notification of intent to import an unlicensed medicinal product
- Import a human medicine
- Guidance on pharmacovigilance procedures
- Exceptions and modifications to the EU guidance on good pharmacovigilance practices that apply to UK MAHs and the MHRA
- Medicines: reclassify your product
- Appendix 1 acceptable intakes established n-nitrosamines
- Guidance on good manufacturing practice and good distribution practice. Q/A
- European Shortages Monitoring Platform fully operational for monitoring of shortages in the EU
- EMA establishes regular procedure for scientific advice on certain high-risk medical devices
- Questions & Answers for applicants, marketing authorisation holders of medicinal products and notified bodies with respect to the implementation of the Regulations on medical devices and in vitro diagnostic medical devices (Regulations (EU) 2017/745 and (EU) 2017/746)
- Mandatory use of ISO/ICH E2B(R3) individual case safety reporting in the EU: hands-on training course using the EudraVigilance system
- Good manufacturing practice
- Nitrosamine impurities in specific medicines
- Reliance for post-authorisation changes: pilots for the pharmaceutical industry
- Good distribution practice
- How CEP holders can avoid the rejection of notifications
- Publication of three new Ph. Eur. general chapters for plastic materials for containers
- Pharmeuropa 37.1 just released
- Replacement of chlorofluorocarbons (CFC) in metered dose inhalation products
- Guideline on the use of near infrared spectroscopy by the pharmaceutical industry and the data requirements for new submissions and variations
- Understanding application audit rules for medical devices including in-vitro diagnostics (IVDs)
- Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs)
- Nitrosamine and Nitroso-structure impurities acceptable intakes update
- Request To Revoke Color Additive Listing for Use of FD&C Red No. 3 in Food and Ingested Drugs
- Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug, and Cosmetic Act
- Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
- Drug Quality Assurance_Outsourcing Facility Inspections
- Advanced Manufacturing Technologies Designation Program Guidance for Industry
- Considerations for Complying With 21 CFR 211.110 Guidance for Industry
- CDER Guidance Agenda
- Use of a Type V Drug Master File for Model Master File Submissions To Support Abbreviated New Drug Applications; Establishment of a Public Docket; Request for Comments
- Expedited Program for Serious Conditions-Accelerated Approval of Drugs and Biologics; Draft Guidance for Industry; Extension of Comment Period
