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Guidance's
MHRA:
- Clinical investigations for medical devices
- 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
- MHRA launches Route B notification pilot as part of clinical trials regulations rollout
- Medical devices: post-market surveillance requirements_Update
- Medical devices: Standardised format for the post market surveillance report
- Medicines: Marketing Authorisation Holders’ submission of Nitrosamine risk evaluation, risk assessment and confirmatory testing_Update
- Apply for manufacturer or wholesaler of medicines licences
- ICH M14 Guideline on general principles on planning, designing, analysing, and reporting of non-interventional studies that utilise Real-World Data for safety assessment of medicines
- Clinical evaluation of medicinal products intended for treatment of hepatitis B – Scientific guideline
- Clinical investigation of medicinal products for the treatment of psoriatic arthritis – Scientific guideline
- New targets for clinical trials in Europe
- A path to better include patients’ perspectives in the regulation of medicines
- Product-specific bioequivalence guidance
- New variations guidelines to streamline lifecycle management of medicines
- Questions and Answers on Implementing Regulation (EU) 2025/1466: Amendment of Regulation (EU) No 520/2012 and Conclusion of the Signal Detection in EudraVigilance Pilot by MAHs
- 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
- EDQM publishes new guidelines on the classification of active pharmaceutical substances as regards their supply
- 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
- ICH E9 (R1) addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials
- Guideline on good pharmacovigilance practices (GVP) Module I – Pharmacovigilance systems and their quality systems
- Guideline on quality documentation for medicinal products when used with a medical device
- 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
- TGA focuses on compliance of AI and software-based medical devices
- Understanding regulation of software-based medical devices
- Have your say on updates to Good Manufacturing Practice (GMP) Guidelines
- Good manufacturing practice (GMP) requirements for medicinal products: PIC/S Guide to GMP PE009-17
- Guide to Refusals and Appeals
- Guide to Withdrawal of Authorisations or Certificates for Human Medicines
- Guide to Notification of Marketing Status of Human Medicines
- Guide to Electronic Submissions – Human Medicines
- Guide for Marketing Authorisation Holders on Direct Healthcare Professional Communications
- Guide to The Notification System for Exempt Medicinal Products
- Guide to Labels and Leaflets of Human Medicines.
- Health Canada updates guidance on management of drug submissions and applications: Notice
- Draft guidance on the plain language labelling regulations for prescription drugs: Overview
- Health Canada publishes proposed changes to increase oversight for precursor chemicals and drug equipment
- Good manufacturing practices guide for natural health products (GUI-0158): Overview, about NHP quality systems
- Health Canada and the Public Health Agency of Canada’s report on red tape reduction
- Upcoming Product-Specific Guidances for Generic Drug Product Development
- Computer Software Assurance for Production and Quality System Software
- E20 Adaptive Designs for Clinical Trials
- Innovative Designs for Clinical Trials of Cellular and Gene Therapy Products in Small Populations
- Expedited Programs for Regenerative Medicine Therapies for Serious Conditions
- FDA Opens Doors for More Treatments for Rare Diseases through the New START Pilot Program
- FDA Advances Rare Disease Drug Development with New Evidence Principles
- Active Pharmaceutical Ingredient (API) Process Inspection Guidance
- Safety Labeling Changes—Implementation of Section 505(o)(4) of the FD&C Act
- Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications
- Development of Non-Opioid Analgesics for Chronic Pain
- E6(R3) Good Clinical Practice (GCP)
- M13B Bioequivalence for Immediate-Release Solid Oral Dosage Forms: Additional Strengths Biowaiver
- Classification Categories for Certain Supplements Under BsUFA III
- Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations Guidance for Industry
- FDA Launches Crackdown on Deceptive Drug Advertising
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submissions of Medical Device Registration and Listing
- Chemistry, Manufacturing, and Controls Development and Readiness Pilot Program; Program Announcement
- 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
- Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; Electronic Submissions of Medical Device Registration and Listing
- Public consultation open on Pharmaceutical Quality System
- Anvisa strengthens regulatory cooperation with Cofepris
- Anvisa participates in IPHEX 2025 in India and reinforces Brazil-India regulatory cooperation.
