International Pharmaceutical Regulatory Monitor Documents Index

May 2016

Polydrug Warning Letter

Jevtana Final Guidance

Praluent Draft Guidance

Repatha Draft Guidance

Mekinist and Tafinlar Draft Guidance

Translarna Draft Guidance

NICE recommendations for Rejected Drugs

Wockhardt Form 483

Pharmacogenomics Guidance

Herceptin Biosimilar Decision

Glenmark 2016 Form 483

Glenmark 2015 Form 483

EMA Guidance on Best Practices for Patient-Reported Outcomes in Oncology Trials

CMA Fine to Pfizer

Off-Label Drug Use Guidance

GSK Appeal

European Warning of Canagliflozin Drugs

India New Drug Price Ceilings

April 2016

FDA Warning Letter to Emcure

EMA Guidance on Marketing Authorization for Orphan Drugs

Treasury’s Temporary Regulations on Foreign Mergers

FDA GMP Import Alert List

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

ANSM Order to Theravectys

Orphan Drug Proposal Consultation Document

NICE Appraisal for Zytiga

NICE Apprasial for Entresto

EMA Pilot Report on Parallel Reviews

EMA Best Practices Guidance

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

Form FDA 483 to Puithampur

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

House Committee Letter to GAO

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 Cadilla

FDA Warning Letter to Sun Pharmaceuticals

FDA Warning Letter to Medisca

New Delhi High Court Order

EC Evaluation Roadmap for Fee System

December 2015

Senators’ Letter on Drug Importation

IMS Report on Global Use of Medicines

Proposal for Cancer Drug Fund

CDSCO Circular on Biologics

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

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

Anvisa’s Data Chart 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

CIRS Study on Drug Approvals

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

EU Guidelines Adopted by TGA

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

National Pharmaceutical Pricing Authority’s Notice on Integrated Pharmaceutical Database Management System

NPPA’s Letter on IPDMS

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

Canada’s Drugs Register

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’

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 List of Suspended Drugs

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 Transparency Policy

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

TGA’s Review of NSAIDs

TGAs Guidance on NSAIDs

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 Clinical Trials Regulation

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

PhRMA’s 301 Submission

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

ICH Photosafety Guideline

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

European Commission’s 4th Report on the Monitoring of Patent Settlements (Period: January-December 2012)

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

EMA’s Orphan Drugs Fee Policy

November 2013

Compromise Amendments on EU Data Protection Proposals

Fact Sheet on Canadian and EU Free Trade Deal

UK Pharmaceutical Price Regulation Scheme

PPRS Consultation Outcome

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

CHMP MCP-Mod Guidance

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

EMA’s Restructuring Plan

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

Mexico Drug GMP Regulation

EMA Member State Contacts for Translation Review

July 2013

EFPIA’s ‘Sunshine’ Code

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 Guideline on Phthalates

EMA’s Concept Paper on Parabens

European Commission’s Summary of Comments on ATMP Regulation

Pfizer‘s Comments on ATMP Regulation

2007 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

TGA’s Guidance on Biologics

Egypt’s Guideline on Submissions for Changes to Parenteral Biological Formulations

EMA’s Consultation on Biosimilar Guideline

TGA’s 2013 Fees List

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

EU Court’s Order

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 Restructuring Plans

EMA’s Extrapolation Concept Paper

EMA’s Revised Labeling Guideline

Labeling Submission Samples

EMA’s Revised GVP Guideline

PRAC’s Tetrazepam Q&A

List of Tetrazepam-Containing Medicines

Protelos/Osseor Q&A

MHRA Five-Year Plan


EMA Biosimilar Guideline

EMA’s List of “Black Triangle” Drugs

Health Canada’s eSubmission Requirements

April 2013

India’s Supreme Court Ruling on Glivec

Medicines Australia’s Report

GS1 Healthcare US’ Draft Guideline

EMA’s Black Triangle Implementation Plan

EU’s GDP Guidelines

European Commission’s Summary of Postauthorization Study Comments

EMA’s 2013 Work Programme

MHRA’s Simplification Proposals

MHRA’s IT Software Announcement

India’s CDSCO Review Order

EMA Draft Guideline on Flu Vaccine Development

EMA Draft Guideline on Clinical Evaluations

EMA’s Draft Guideline on Protein-Modified Drugs

NIC Concordat

MHRA’s List of Regulations and Proposed Actions

EMA’s Revised Fee Schedule

EMA’s Fee Explanatory Guide


COFEPRIS’ Labeling update

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

EMA’s SME User Guide

Colombia’s GLP Guidance (in Spanish)

Canada’s Table on Brand Drug Labeling Changes

February 2013

EU Transparency Directive

UK health committee report on value-based pricing

EU GMP Guidelines

EU- Israel GMP Accord

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

EMA SmPC 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

IFPMA Report on Counterfeit Medicines

CDSCO Draft Guideline on Good Distribution Practices