International Pharmaceutical Regulatory Monitor Documents Index
May 2016
Mekinist and Tafinlar Draft Guidance
NICE recommendations for Rejected Drugs
EMA Guidance on Best Practices for Patient-Reported Outcomes in Oncology Trials
European Warning of Canagliflozin Drugs
April 2016
EMA Guidance on Marketing Authorization for Orphan Drugs
Treasury’s Temporary Regulations on Foreign Mergers
FDA Refusal of Inspection Import Alert List
ANSM Report on Bial Clinical Trial Disaster
EMA Data Extrapolation Framework
India Guidelines on Biosimilar Development
Novartis Bribery Settlement with SEC
Orphan Drug Proposal Consultation Document
EMA Pilot Report on Parallel Reviews
March 2016
EC Study on Enhanced Coordination on Drug Prices
Sidley Austin Summary of CFDA’s Priority Pathway
Sidley Austin Summary of CFDA’s Rules for Clinical Data Verification
EMA and EC Packaging Safety Implementation Plan
EMA Guidance on Implementing Disclosure Policy on Clinical Data
PhRMA’s Special 301 Submission for 2016
NHS England Board Paper on Reforming Cancer Drugs Fund
FDA Warning Letter to Ipca Laboratories
EMA Request for Comments on Revising Module V of GVP
February 2016
EMA Report on Drug Recommendations
France’s General Inspectorate of Social Affairs Report (in French)
Merck Complaint in U.S. District Court for the District of New Jersey
EMA Draft Guideline on Medicines for Alzheimer’s Disease and Dementia
India Ministry Notice on Implementation of Track-and-Trace System
FDA Warning Letter to Chan Yat Hing Medicines Factory
UK House of Commons’ Committee Report on Cancer Drug Funds
January 2016
MHRA’s Pharmacovigilance Inspection Metrics Report
Gazette of India Notice on Price Increases
JAMA Article on Affordability of Off-Patent Pharmaceuticals
India’s National List of Essential Medicines
India Notice on Committee Recommendations
FDA Warning Letter to Sun Pharmaceuticals
EC Evaluation Roadmap for Fee System
December 2015
Senators’ Letter on Drug Importation
IMS Report on Global Use of Medicines
BMS’ License and Technology Transfer Agreement
IMA Statement of Non-compliance with GMP
Delhi High Court Ruling in Patent Case
November 2015
Text of the Trans Pacific Partnership
EMA’s Pharmacovigilance Program Update
EU’s Annex 16: Certification by a Qualified Person and Batch Release
EMA’s EudraVigilance System Changes
EFPIA Policy Principles for Off-Patent Biologics Medicines in Europe
Decision of European Ombudsman on Public Access to
Reports
Ruling in Seattle Genetics Inc. v. Austrian Patent Office
EMA’s Electronic Submission on Medicinal Products forHuman Use by Marketing Authorisation Holders
ICH’s Q3C Impurities: Residual Solvents
WHO’s Notice of Concern Letter to Svizera Labs
WHO’s Facts on Prequalification of Drugs by WHO
Anvisa’s Technical Note on Fees
EFPIA’s Proposal on Conditional Marketing Authorization
EMA’s Guideline on Developing Antibiotics
ICH’s M7(R1) Addendum to ICH M7
FDA’s Draft Guidance on Formal Dispute Resolution
ICH’s Addendum on E6(R2) Good Clinical Practice Guideline
PAHO/WHO’s Acta on Access to Drugs
FDA’s Notice on FY2016 Tropical Disease Voucher Fees
September 2015
U.S. FDA’s Nonproprietary Naming of Biological Products
U.S. FDA’s Proposed Rule on Naming Biologicals
EU’s Telematics Strategy and Implementation Roadmap 2015-2017
EMA’s Guideline on Good Clinical Practice
EMA’s Draft Guideline on Postauthorization
EMA’s Addendum on Safety Studies
EMA’s Guidance on Pharmacovigilance Audits
EMA Pharmacovigilance Inspectors Working Group’s 2014 Report
EMA’s Manual on Medical Literature Monitoring Service
EMA’s Question & Answer Document on MLM
U.S. FDA’s Draft Guidance on CMC Changes
U.S. FDA’s Final Order on Tropical Diseases
Saudi FDA’s Guidance on Clinical Trials
IPEC-America’s Position Paper on Excipients
U.S. FDA’s Final Guidance on Shedding Studies
August 2015
European Commission’s Decision Banning Drugs
Annex Listing Drugs Affected by EU Ban
FDA Quality Metrics Draft Guidance
EMA’s Guideline on Accelerated Assessment
EMA’s Guideline on Conditional Marketing Authorization
EMA’s Draft Guideline on Finished Dosage Forms
Health Canada’s Notice on APIs
ICH’s Draft Q3C (R6) Guideline
FDA’s Immediate-Release Dissolution Draft Guidance
EMA’s Guideline on Postauthorization Procedural Advice
EMA’s Guideline on Flu Vaccines
Comments on Revisions to TGA’s Orphan Drug Program
Standing Committee’s Report on Drug Pricing in India
NPPA’s Notice on Price Controls
Department of Pharmaceuticals Report on Drug Industry Growth in India
July 2015
Canada Rx&D’s Report on Access to New Drugs
EMA’s Draft Addendum on Acute Heart Failure
EMA’s Final Guideline on Acute Heart Failure
EMA’s Paper on Cardiovascular Risks
EMA’s Q&A on Pediatric Investigation Plans
EMA’s Paper on Advanced Therapy Medicinal Products
EMA’s Guidance for Drug Importers
EMA’s Preauthorization Procedural Advice
Health Canada’s Guidance on Plain Language Labeling
TGA’s Regulator Performance Framework
European Parliament’s Compulsory Licensing Question
European Commission’s Compulsory Licensing Answer
June 2015
House Energy & Commerce Committee’s 21st Century Cures Act
TGA’s Discussion Paper on Orphan Drugs
HHS Office of Inspector General’s Report on Generic Drugs
Association of British Pharmaceutical Industries’ Report on Clinical Trial Transparency
Health Canada’s Final Guidance on Third-Party Data for Submissions
EMA’s Guideline on Conflicts of Interest
Saudi FDA’s Requirements for Import, Clearance and Export
Saudi FDA’s Regulations on Transporting and Storing Drugs
UK Report on Antibiotics Pipeline
EMA’s Draft Guideline on Fixed Combination Products
EMA’s Annual Report on EudraVigilance
U.S. FDA’s Draft Guidance on Waiver of BA/BE Studies
U.S. FDA’s Final Guidance on Electronic Submissions
U.S. FDA’s 2015 Guidance Agenda
May 2015
EU’s Annex 15 to GMP Guideline
EMA’s Analysis of Scientific Advice
EMA’s Concept Paper on Generic Topical Drugs
PIC/S’ Annex 15 on Guide to GMPs
EMA’s Draft Guideline on Reporting Medication Errors
EMA’s Draft Guideline on Risk Minimization
EMA Addendum to Insulin Guideline
New Zealand’s Guideline on Pharmacovigilance
EMA’s Draft Guideline on Deep Vein Thrombosis Drugs Development
EMA’s Comments on Insulin Biosimilars
Canada’s Drug and Health Product Inspections Database
TGA’s Consultation on 10 EU Guidelines
Japan’s Outline on Regenerative Drug Approval Pathway
April 2015
Australia’s Guidance on Postmarket Reviews
India’s Guidance on Trial Accreditation Requirements
China’s Guideline on Establishing Biosimilarity
EMA’s Guideline on Insulin Biomarkers
Comments on Insulin Biomarkers Guideline
France’s Action Plan on Generics
Canada’s Guidance on Disclosure Under Vanessa’s Law
Canada’s Survey on Vanessa’s Law Guidance
China’s Guideline on Centralized Procurement of Drugs
EMA’s Explanatory Note on Pharmacovigilance Fees
EMA’s Explanatory Note on Agency Fees
Medicines Australia’s Submission on Cancer Drugs
Cancer Drugs Alliance’s Comment Submission
IQWiG’s Comments on ‘Commercially Confidential’
Definition
White House Plan to Combat Antibiotic-Resistant Bacteria
Canada’s Guidance on Reconsideration of Decisions
March 2015
Mexico’s Regulation on Biosimilars
EU Ombudsman’s Inquiry on Humira Trial Report Redaction
EU Ombudsman’s Complaint on Humira Study Redaction
EMA’s Response to EU Ombudsman
China and Switzerland’s Bilateral Agreement
TGA’s Consultation on Warning Labels for NSAIDs
EMA’s Guidance on Response Meetings
EMA’s Q&A Guideline on Type II Variations
EMA’s Concept Paper on Sterile Drug GMPs
NPPA’s Compendium on Essential Drug Price Caps
Public Citizen’s Petition on Ketoconazole
DTAP’s Recommendation on Phase III Trials
February 2015
EMA’s Proposal on Transparency of Clinical Trials Portal and Database
EMA’s Draft Appendices to Transparency Proposal
India’s Draft Bill Amending the Food and Cosmetics Act, 1940
CDSCO’s Formula for Clinical Trial Compensation
EMA’s Information Package on International Generic Regulators Pilot
EMA’s Guideline on Similar Biological Medicinal Products
EMA’s Updated Guideline on Pediatric Investigation Plans
EMA’s Q&A on Compliance Checks for PIP Submissions
EMA/Heads of Medicines Agencies’ Guide on Reporting Adverse Events
Comments on TGA’s Label Requirements
U.S.-India Joint Statement on Intellectual Property
CIRS Report on Drug Approval Times
Medicines Australia’s Comments on Improving TGA Framework
CDSCO’s Notice on Presubmission Meetings
MCC’s Guidance on Drug Naming in South Africa
January 2015
Clinical Pharmacology & Therapeutics on the EMA’s Adaptive Pathways Program
ABPI’s Report Comparing International Medicines Usage
Brazil’s Revised Framework for Product Development Partnerships
Comments on the EMA’s Draft Guideline on Biosimilars
CDSCO’s Draft Standard on Clinical Trial Ethics and Accreditation
National Pharmaceutical Pricing Authority’s Price Controls for 52 Drugs
European Commission’s Report on Monitoring of Patent Settlements
PMDA’s Revised Regulation on Premarket Review of Combo Products
Medsafe’s Uniform Recall Procedures
U.S. Department of Health and Human Services’ Notice on Ebola Vaccine Liability
Health Canada’s Guidance on Content of Batch Certificates for Drugs Exported Under an MRA
December 2014
EMA’s Letter of Support for Kidney Disease Biomarker Research
EU Ombudsman’s Letter on EMA Trial Data Transparency
EMA’s Response to Ombudsman Letter
EUnetHTA’s Draft Harmonized Framework for Cost Assessment
NPPA’s Notice on Fixed-Dose Combination Products
CDSCO’s Notice on API Stability Data
Health Canada’s Partial Lift on Indian Drugmakers Import Ban
EMA’s Draft Guideline on Influenza Vaccine Submissions
EMA’s Guideline on Similar Biological Medicinal Products
Indian Pharmaceutical Alliance’s comments on 2014 Special 301 Out-of-Cycle Review of India
EMA’s User Manual for XEVMPD Bulk Update Manager
UK Department of Health’s Consultation on MHRA Triennial Review
U.S. FDA’s Notice on Study to Assess Effect of Frequency on DTC Ad Perception
November 2014
EMA’s Brochure on How to Report ADRs
WikiLeaks Copy of Draft Trans-Pacific Partnership Trade Pact
U.S. Trade Representative’s Notice on Out-of-Cycle Review of India
USTR’s 2014 Special 301 Report
Indian Pharmaceutical Alliance’s Study on Intellectual Property and Foreign Direct Investment
CDSCO’s Order on Expert Review Committee
EuropaBio’s Position Paper on Biosimilars
EuropaBio’s Biosimilars Guidance
EMA’s Specifications for Transparency Portal and Database
EFPIA’s Position Paper on Transparency Portal and Database
Health Canada’s Guidance on Trial Applications for Cell Therapy Products
Department of Health and Ageing’s Terms of Reference for Independent Review
Australia’s Innovation Action Plan
ANMAT’s Guidance on Applying for Premarket Inspections
Health Sciences Agency’s Proposed Rule on Ads
HSA’s Explanatory Guidance on DTC Ads
October 2014
Canadian Competition Chief’s Remarks on Generic Pay-to-Delay Deals
EMA’s Q&A Document on Adaptive Licensing Pilot Project
EMA’s Module VI of the Good Pharmacovigilance Guideline
EMA’s Module III of the Good Pharmacovigilance Guideline
Comments on Module VI of the EMA’s Good Pharmacovigilance Guideline
EMA’s M7 Guideline on Assessment and Control of DNA Reactive (Mutagenic) Impurities
CDSCO’s Order on Clinical Trials
NPPA’s Order on Drug Shortages
NPPA’s Notice on an Integrated Pharmaceutical Database Management System
NPPA’s Withdrawal of Internal Procedural Guideline
NICE’s Consultation on Value-Based Assessments
EMA’s Postauthorization Procedural Advice
TGA’s Guidance on Nonclinical Studies
TGA’s Consultations on Adoption of EU Guidelines
EMA’s Guideline on Good Pharmacovigilance for Vaccines
September 2014
EMA’s Pilot Program on Generic Drug Approvals
CDSCO’s Letter on Procedures of Regulatory Inspection
Health Canada’s Drug Submissions Dispute Resolution Process
Canadian Health Policy Institute’s Study of Canadian vs. EU Drug Approvals
EMA’s Draft Guideline on Seasonal Influenza Vaccines
EMA’s Draft Policy on Access to Adverse Event Data
MHRA Consultation on Listing of Safety Features on Drugs
Anvisa’s Draft Rule on Product Development Partnerships
Anvisa’s Flowchart for PDP Submission and Analysis
TGA’s Consultation on Medicines Labeling
TGA’s Proposed eCTD Submissions Process
Anvisa’s Guideline on a National Drug Tracking System
Anvisa’s Proposed Regulation on Registration of Clinical Trials
Philippines FDA’s Revised Regulations on Drug Labeling
Philippines FDA’s List of Specific Labeling Materials
PIC/S Guidance on Good Distribution Practice for Medicines
August 2014
EMA’s Pharmacovigilance System Manual
Comments on Adoption of EU Guidelines in Australia
EU Ombudsman’s Ruling on EMA Rejection of Migraine Drug
Ireland’s List of 12 Active Substances for OTC Use
Industry Comments on EMA/HTA Parallel Scientific Advice Pilot
Advocacy Group Comments on EMA/HTA Parallel Scientific Advice Pilot
Innovative Medicines Initiative’s Strategic Research Agenda
CDSCO’s Clinical Trial Regulations
Health Canada’s Regulations on Labeling, Packaging and Brand Names of Drugs
India’s Reward Scheme for Whistleblowers of Spurious Drugs
Alliance Life Sciences’ White Paper on the GCC Price Harmonization Process
Medicines Australia’s Proposed Industry Conduct Code
Therapeutic Goods Amendment (Pharmaceutical Transparency) Bill 2013
Sweden’s Guideline on Drug Labeling and Package Leaflets
Philippines FDA’s Regulation on OTC Drug Registration
July 2014
EMA’s Union Procedure on the Management of Pharmacovigilance Inspection Findings
EMA’s Regulation on Pharmacovigilance Activities Fees
NPPA Order on Price Controls for Generics
Indian Pharmaceutical Alliance’s letter to Department of Pharmaceuticals
India’s Notice on Drug Barcoding Procedures
Anvisa’s Rule on Clone Applications (in Portuguese)
Anvisa’s Rule No. 37 and Normative Instruction No. 3 (unofficial translation)
Anvisa’s Rule No. 37 and Normative Instruction No. 3 (in Portuguese)
European Commission’s Guideline on Result-Related Information on Clinical Trials
European Union’s Clinical Trials Register
EudraCT Clinical Trials Database
TGA’s Consultation on Adoption of EU Drug Development Guidelines
EMA’s Reflection Paper on Classification of Advanced Therapy Medicinal Products
NICE Guidance on Management of Atrial Fibrillation
TGA’s Required Advisory Statements for OTC Medicine Labels
June 2014
EMA’s Draft Guideline on Parallel Reviews With HTABs
EU Ombudsman’s Letter to EMA Director Rasi
U.S. FDA/EMA Joint Strategic Plan on Development of Drugs for Pediatric Gaucher Disease
UK Centre for Innovation in Regulatory Science’s Report on New Drug Approvals in ICH Countries
FDA Voice Blog on Use of Accelerated Approval Tracks
EMA’s Guideline on Acceptability of Names for Human Drugs
U.S. FDA Draft Guidance on Demonstrating Biosimilarity
INVIMA’s Draft Resolution on GMPs for Biological Medicines
May 2014
India’s Draft Amendments on Clinical Trial Compensation
India’s Trial Compensation Formulae
EMA’s Guideline on Nonclinical Local Tolerance Testing of Medicines
EMA’s Delegated Act on Situations in Which Postmarketing Studies May Be Required
EMA’s Guideline on Neoadjuvant Breast Cancer Studies
European Commission’s Centralized Procurement System for Pandemic Vaccines
EMA’s Guideline on Development of Insulin Biosimilars
EMA’s Guideline on Process Validation in Manufacture of Biotech-Derived Proteins
GPhA/EGA Letter to Transatlantic Trade and Investment Partnership Negotiators
European Commission’s GMP Guideline on Quality Control
EMA’s Medication Error Action Plan
EMA Guideline on Security of Electronic Safety Reports
U.S. FDA Rule on Destruction of Detained Drug Imports
TGA’s Staged Implementation Plan for OTC Business Process Reform
April 2014
EMA’s Influenza Vaccine Strain Recommendations
EMA’s Adaptive Licensing Application
NICE’s Proposal on Broadening Assessment Measurements
EMA’s First Published Risk Management Plan Summary
Swissmedic’s Biosimilar Authorization Q&A
European Survey on Same-Name Biosimilars
EU’s Second Innovative Medicines Initiative Regulation
March 2014
EMA Guideline on Pharmacovigilance Risk-Minimization Measures
EMA Guideline on Use of Porcine-Derived Products
MHRA Annual Report on Drug Advertising
PhRMA’s Letter to the U.S. Trade Representative
EMA Draft Guideline on Clinical Subgroup Investigations
CDSCO Guidance on Approval of Stem Cell-Based Products
CDSCO’s Memo on Shelf-Life Requirements for Imported Drugs
February 2014
CDSCO Draft Guideline on Audiovisual Recording of Informed Consent
CDSCO Trial Compensation Formula
EMA Guideline on Novel Drug Development Tools
EMA Guideline on Lipid Disorder Drugs
Draft National Policy on Intellectual Property (IP) of South Africa
EMA Q&A Guideline on Postmarket Safety Reporting
EMA Guideline on Pharmacogenomics
MHRA Guidance on Handling Quality Defects
Health Canada Guidance on Quality in Drug Development
European Commission Guideline on Annex 15 to EU GMPs
PMDA Memo on Postapproval GMP Requirements
Health Canada Guideline on Drug Labeling
Scottish Report on Patient-Centered Research
January 2014
Compromise Proposal on EU Clinical Trial Regulation
Anvisa’s Resolution RDC 54/2013 (In Portuguese)
European Commission’s Notice for HTA Early Dialogue Pilot
Health Canada’s Updated Guidance on Prescription Drug Submissions
Health Canada’s Guidance on Streamlining Trials Using Positron-Emitting Radiopharmaceuticals
December 2013
Ministry of Health and Family Welfare’s Report on Clinical Trial Oversight
India’s Order Requiring Use of Audiovisual Consent in Clinical Trials
TGA’s Batch Release Draft Guidance
Canada’s Protecting Canadians from Unsafe Drugs Act
EMA’s Draft Guideline on Urokinase-based Drugs
U.S. Drug Quality and Security Act
November 2013
Compromise Amendments on EU Data Protection Proposals
Fact Sheet on Canadian and EU Free Trade Deal
UK Pharmaceutical Price Regulation Scheme
ABPI’s Proposed ‘Sunshine’ Provisions
EC Guidance on Publishing Result-Related Clinical Trial Information
EC Technical Guidelines on Formatting Result-Related Trial Information
PRAC Recommendation on Safety Signals
Q&A on the EMA’s Signal Management
EC Guideline on Pediatric Investigation Plans
Addendum to EMA’s Guideline on Developing Antibacterial Drugs for Unmet Needs
EMA Guideline on Developing Antibacterial Drugs for Unmet Needs
EMA Guideline on the Collection, Verification and Presentation of Adverse Event Reports
Risk Sciences International’s Report on Canadian Recalls
October 2013
EMA’s Draft Guideline on Clinical Development of Medicines for Treatment of HIV Infection
EU Ombudsman’s Closing Report on EMA Transparency
Health Research Authority’s Paper on Good Research Conduct in the UK
Chaudhury Report on Drug Policy in India
India’s Guidelines for Approval of Fixed-Dose Combination Drugs
India’s Drugs and Cosmetics (Amendment) Bill, 2013
Health Canada’s Draft Guidance on Requirements for Subsequent Entry Biologics
Health Canada’s Multi-Stakeholder Toolkit on Responding to Drug Shortages
U.S. FDA’s Draft Guidance on Bioanalytical Method Validation
U.S. FDA’s Final Guidance on Electronic Source Data in Clinical Trials
EMA’s Draft Pediatric Addendum to Guideline on Clinical Trials of Medicines to Treat Hypertension
Australia’s New Schedule of Pharmaceutical Benefits
Australia’s Final Budget Outcome
Colombia’s Updated Drug Tariffs List (In Spanish)
September 2013
India’s Trial Compensation Notice
Drug & Cosmetics (Amendment) Act, 2013
Indian Parliament Committee’s Report on FDI in the Pharma Sector
EMA’s Report on Routine vs. For-Cause GCP Inspections
Brazil’s Antibribery Law (In Portuguese)
Brazil’s Decree on New GMP Framework (In Portuguese)
EU Parliament Committee’s Amendments to Precursor Regulations
U.S. FDA-EMA Joint Assessment of Qbd Pilot
ASEAN Draft Guidance on Qbd Validation Approach
U.S. FDA’s Draft Rule on Border Medicines Detentions
Notice of EMA-U.S. FDA Joint Orphan Product Meeting
U.S. Federal Trade Commission’s Amicus Brief
Colombia’s Vaccine Regulation Proposal (In Spanish)
August 2013
Biotechnology Regulatory Authority of India Bill, 2013
CDSCO Draft Rules on Compensation in Death or Injury
India Draft Guideline on Trial Compensation
EMA Guideline on Qualified Persons and Batch Releases
WHO Quality Risk-Management Guideline
ICH Guideline for Elemental Impurities Q3D
U.S. FDA Proposed Rule Granting Detention Authority for Drugs
U.S. FDA Guidance on Penalties for Refusing an Inspection
EU Q&A on Postauthorization Updates
EC Update on Drug Labeling Requirements
EMA Draft Trial Transparency Policy
PhRMA and EFPIA’s Principles for Trial Data Sharing
Ombudsman Report on Pediatric Trials Waiver Process
Ruling Overturning EMA’s Decision on Orphacol
EUCERD Report on Orphan Drugs in the EU
CHMP Decision on GLP-1 Diabetes Drugs
TGA Listing of Biosimilar Guidelines
Ontario Health Ministry Report on Drug Compounding
EMA Member State Contacts for Translation Review
July 2013
TGA’s Draft Proposal on Releasing Commercially Confidential Information
EC’s Proposed Anticompetitive Practices Directive
U.S. Supreme Court Ruling on Patentability of Isolated DNA
Alliance for Fair Trade’s Letter to U.S. President Barack Obama
Pfizer’s U.S. House Subcommittee Testimony
Indian Pharmaceutical Alliance’s Letter to Pfizer on IP Practices
Indian Pharmaceutical Alliance’s Rebuttal Letter to Pfizer’s U.S. House Testimony
EMA’s Proposed Policy for Increasing Access to Clinical Trial Data
EMA’s Revised Guidelines on Postmarket Reporting
EMA’s Guideline on Postmarketing Procedural Advice
Health Canada’s Updated User Fee Guidance
Health Canada’s Guidance on Fees for Marketing Rights
Notice on EMA/U.S. FDA Common Orphan Drug Applications
U.S. FDA’s Final Orphan Drug Regulations
U.S. FDA’s Guidance on Stability Testing of ANDAs
June 2013
European Commission’s Proposed Clinical Trials Regulation
Health Research Authority’s Testimony on UK Clinical Trials
Health Canada’s Clinical Trials Database
Health Canada’s Guidance on Inclusion of Women in Clinical Trials
EMA’s Pharmacogivilance Amendments
U.S. Trade Representative’s Report on IP Rights
Information Technology & Innovation Foundation’s Report on Indian Trade Policies
Indian Pharmaceutical Alliance’s Response to U.S. Congress
CDSCO’s Guidelines for Issue of Written Confirmation
Health Canada’s GMP Amendments
EMA’s Concept Paper on Parabens
European Commission’s Summary of Comments on ATMP Regulation
Pfizer‘s Comments on ATMP Regulation
Interfarma’s Report on Rare Diseases
EMA’s Guideline on Orphan Drug Designation Applications
EMA’s Advice on Appealing Orphan Designations
European Commission Working Group’s Report on Coordinated Access to Orphan Products
Australia and New Zealand’s Early Warning System
TGA’s Guidance on Chemical Variations
Egypt’s Guideline on Submissions for Changes to Parenteral Biological Formulations
EMA’s Consultation on Biosimilar Guideline
Australia’s GMP Codes for Human Blood, Blood components, Tissues and Cellular Therapy Products
Kenya’s e-Pharmacovigilance Reporting System
May 2013
AbbVie’s Response to the Australian Draft Bill
Medicines Australia’s response to Draft Transparency Bill
Advisory Group’s Clinical Trial Data Documents
EU Panel’s Memorandum on Orphan Drug Progress
EMA’s Clinical Trial Recruitment Report
ICH’s Guideline on Evaluating Carcinogenic Risk
EMA’s Extrapolation Concept Paper
EMA’s Revised Labeling Guideline
List of Tetrazepam-Containing Medicines
EMA’s List of “Black Triangle” Drugs
Health Canada’s eSubmission Requirements
April 2013
India’s Supreme Court Ruling on Glivec
GS1 Healthcare US’ Draft Guideline
EMA’s Black Triangle Implementation Plan
European Commission’s Summary of Postauthorization Study Comments
MHRA’s Simplification Proposals
MHRA’s IT Software Announcement
EMA Draft Guideline on Flu Vaccine Development
EMA Draft Guideline on Clinical Evaluations
EMA’s Draft Guideline on Protein-Modified Drugs
MHRA’s List of Regulations and Proposed Actions
March 2013
EMA’s Rhabdomyosarcoma Pediatric Investigation Plan
EMA’s Acute Myeloid Leukemia Pediatric Investigation Plan
EMA’s Reflection Paper on Master File Retention
EMA’s Guideline on Virtual Pharmacovigilance Inspections
India’s Proposed Methodology on Drug Verification
India’s Requirements for Trial Ethics Committees
EMA’s Carcinogenic Risk Guideline
EMA’s Porcine Trypsin Guideline
EMA’s 2012 Annual Report on SMEs
Colombia’s GLP Guidance (in Spanish)
Canada’s Table on Brand Drug Labeling Changes
February 2013
UK health committee report on value-based pricing
EC Clinical Trials Transparency Report
EMA Elderly Cancer Study Guideline
EU-Japan Nanotechnology Reflection Paper
India’s Final Rule on Clinical Trials
India’s Final Rule on Trial Compensation
CDSCO Notice on Fixed-Dose Combination Drugs
U.S. Combination Products Guidance
Philippines Guideline on eCopy Submissions
• Appendix 2
• Appendix 3
January 2013
European Commission’s Frequently Asked Questions on the Unified Patent System
EU, New Zealand Mutual Agreement on GMP, Inspections
ANZTPA Draft Framework for Joint Regulatory Scheme
EMA Draft Guideline on Contamination Risk Testing
EMA Draft Guideline on Pediatric Drug Development
Pharmexcil Memo on Indian Barcode Implementation