Table of ContentsAppendices are noted with an asterisk* and can be found on the disc in the

back of this book.

Introduction

Adverse Drug ReactionsTGA Harmonizes Adverse Event Reporting Terms Requirements, 8/11 .......................................3

Australian Guideline for Pharmacovigilance Responsibilities of Sponsors of Medicines*Facebook Ends Drugmakers’ Option to Edit Comments on Facebook Pages, 9/11 ......................4

Antibacterial DrugsEMA Meets With Industry Stakeholders to Discuss Antibacterials Guideline Revamp, 5/11 ......9

EMA Guideline on the Evaluation of Medicinal Products Indicated for Treatment of Bacterial Infections*

EMA Workshop on Antibacterials*

Application, Approval, Authorization, Registration, Regulatory ReviewU.S. Legislators Propose Drug Safety Regulations through Global Oversight, 1/11 ..................13

Drug Safety Enhancement Act of 2011*MoU Means Increased Cooperation For Ireland’s Healthcare Regulators, 1/11 .........................14Europe to Increase Collaboration With Asian Health Agencies, 1/11 .........................................15EMA Expects Slight Rise in Applications In 2011, Adopts Work Program, 1/11 .......................16EMA ‘Road Map to 2015” Focuses on Public Health, Improved Access, Drug Safety, 1/11 .....17

The European Medicines Agency Road Map to 2015: The Agency’s Contribution to Science, Medicines, Health*

Pricing Reforms, Biosimilars and Cracking Down On Company Misconduct 2010 Themes, 1/11 .............................................................................................................................19

Developing Biosimilar Guidance .................................................................................................20Czech Healthcare Reforms Likely to Impact Pharmaceutical Industry, 2/11 ..............................22NHS Reforms Mean More Competition Between Public and Private Providers, 2/11 ...............24

Health and Social Care Bill 2010-11*The Operating Framework for the NHS in England 2011/12*

EMA to Drugmakers: Translate Product Info Into Croatian Before Accession, 3/11 ..................27Pre-accession Linguistic Check for Croatian Underway*

iv FDAnews Guide to International Pharma Regulation: 2012 Edition

Pre-accession Product Information Linguistic Review Process (PALC III)*Timetable for Sending of Translations to Croatia*Practical Guidance on the Extension of Commission Decision Annexes in the New Accession

Country Language*ENCePP Sets Goals for 2011, 2012 to Enhance Role in Pharma Industry, 3/11 .........................28

ENCePP Work Plan 2011-2012*EMA Increases Application, Marketing Authorization Fees by 2.1 Percent, 4/11 ......................29

EMA Increased Fees Coming into Effect on 1 April 2011*Drugs Easier to Search on Overhauled Australian Register of Therapeutic Goods, 4/11 ............30

eBS Australian Register of Therapeutic Goods Medicines*EDQM’s Expert Committee Begins Annual Review of Prescription, OTC Medicines, 4/11 .....31Brazil, China Meet to Discuss Pharmaceutical Regulatory Issues, 4/11 .....................................33FDA, EMA to Conduct Parallel QbD Reviews as Part of New Pilot Program, 4/11 ..................34Task Force to Address India’s Pharmaceutical Industry Issues, 4/11 ..........................................35Health Canada Changes Expiration Policy, Revamps Establishment License Protocols, 5/11 ...36

Health Canada HPFB Inspectorate: Establishment Licensing*Brazil Improves Drug Assessment For National Health System, 6/11 ........................................37Chile Could See New Drug Agency Under Proposed Reforms , 6/11 .........................................38Joint Australia, NZ Regulatory Agency Streamlines Drug Registration, 7/11 ...........................40EMA to Meet Roadmap Goals Through Adaptive Licensing, Other Initiatives, 7/11 .................42PMDA Aims to Speed Reviews, Consult Earlier with Industry, 7/11 ..........................................44India Code Bans Bribery, Regulates Drug Marketing, 7/11 ........................................................47

Code of Marketing Practice for Indian Pharmaceutical Industry*Estonia Clarifies Requirements for Drug Advertisements, 10/11 ................................................49France Passes Sweeping Drug Regulation Reforms, 10/11 .........................................................50South Korea Proposes Five-Year Reregistration for Drugs, 10/11 ..............................................51EC Wants Feedback on Extending Variations Reg to National Authorities, 10/11 .....................52Devicemakers Say EU Approval Path Doesn’t Trump U.S. FDA’s, 10/11 ..................................54UK Seeks Stakeholder Input on Consolidation of Drug Regulations, 11/11 ...............................56

Consolidation and Review of UK Medicines Legislation*New Medicines Show to Reach New Zealanders. 12/11 .............................................................58Canada Scores Low Grade on Drug Regulation, 12/11 ...............................................................59

Report of the Auditor General of Canada to the House of Commons: Regulating Pharmaceutical Drugs — Health Canada*

Table of Contents v

BiologicsArgentina Launches Regulatory Framework for Biologicals, 11/11 ...........................................63

BiosimilarsEGA Calls for Improved Regulations For Biosimilars in the EU, 5/11 .......................................67US FDA, EMA Collaborate To Harmonize Biosimilars Pathways, 7/11 ....................................68U.S. Lawmakers Split on Biosimilar Exclusivity in TPP Negotiations, 8/11 ..............................70

Letter from Congress to the President: U.S. Lawmakers Split on Biosimilar Exclusivity in TPP Negotiations*

Letter from Congress to the President: U.S. Lawmakers Split on Biosimilar Exclusivity in TPP Negotiations*

GPhA Seeks Tighter Time Frames For Biosimilar Development Meetings, 9/11 .......................71EMA: Biosimilars Guideline Revisions Needed, 11/11...............................................................72

Concept Paper on the Revision of the Guideline on Similar Biological Medicinal Products Containing Biotechnology-Derived Proteins as Active Substance: Non-clinical and Clinical issues*

Cancer Drugs/TestingUK’s NHS Promises Better Access to Cancer Testing and Treatment, 2/11 ...............................77

Improving Outcomes: A Strategy for Cancer*Earlier Treatment of Colorectal Cancer Reduces Mortality Rate, 3/11 .......................................79

European Guidelines for Quality Assurance in Colorectal Cancer Screening and Diagnosis*EU Approves Novartis’ Afinitor To Treat Pancreatic Tumors, 9/11 ...........................................80EC OKs Roche’s Tarceva for First-Line Use in Distinct Form of NSCLC, 9/11 ........................81

Clinical TrialsEMA to Give Case by Case Review for Active Controls in Trials, 2/11 .....................................85

Reflection Paper on the Need for Active Control in Therapeutic Areas Where Use of Placebo Is Deemed Ethical and One or More Established Medicines Are Available*

UK Drug Trials to be Under Review of Proposed Agency, 2/11 .................................................86Australian Pharma Industry Proposes Tactics to End Clinical Trial Decline, 3/11 .....................88

Key Issues Affecting the Medicines’ Industry’s Medical Research in Australia*EU to Step Up Regulation of Clinical Trials Done in Developing Countries, 3/11 ....................89Medicines Australia Reminds Government New Trial Regulations Are Necessary, 4/11 ...........91

Clinically Competitive: Boosting the Business of Clinical Trials in Australia*UK’s Medicine Regulator Initiates New Notification Scheme for Clinical Trials, 4/11 ..............92

vi FDAnews Guide to International Pharma Regulation: 2012 Edition

Clinical Trials for Medicines: Submitting a Notification for a Trial*ENCePP Finalizes Guide on Drug Study Design, 6/11 ...............................................................93

Overview of Comments Received on the ‘ENCePP Guide on Methodological Standards in Pharmacoepidemiology’ (EMA/95098/2010)*

EMA to Include Ethical Consideration For Clinical Trials in MAAs, 6/11 .................................94Draft Reflection Paper on Ethical and GCP Aspects of Clinical Trials of Medicinal Products

for Human Use Conducted in Third Countries and Submitted in Marketing-Authorisation Applications to the EMA*

Finland Industry, Government Work to Trial Competitiveness, 6/11 ..........................................96Medicines Policy 2020: Towards Efficient, Safe, Rational and Cost-Effective Use of

Medicines*Guidance on India Clinical Trials Standardizes AE Reporting, 6/11 ...........................................97

Draft Guidance for Industry on Reporting Serious Adverse Events Occuring in Clinical Trials*

Russia Clinical Trials Decline In Early 2011 Versus 2010, 7/11 .................................................98Clinical Trials in Russia Orange Paper 1st Quarter 2011*

EU Working Toward Common Clinical Trial Application for All Member States, 7/11 ...........101Centralized Monitoring Urged For Clinical Trial Oversight, 9/11 ............................................102

Guidance for Industry Oversight of Clinical Investigations — A Risk-Based Approach to Monitoring*

African Clinical Trial Registry Gets Searchable Mapping System, 9/11 ..................................104Report Compares Clinical Trials In Latin America and the U.S., 9/11 ......................................105

Latin American Physicians’ Attitudes Toward Participation in Clinical Trials*EU Clinical Trials Directive Reforms Badly Needed, Groups Say, 10/11.................................106

Revision of the ‘Clinical Trials Directive’ 2001/20/EC Concept Paper Submitted for Public Consultation*

Canada Outlines Requirements for Clinical Trial Applications, 11/11 ......................................108Release of the Draft Guidance Document: Clinical Trial Sponsors - Clinical Trial

Applications*Revised Draft Guidance Document: Preparation of Drug Submissions and Applications in the

Common Technical Document (CTD) Format*First-Ever Survey to Support Clinical Trials in Australia, 12/11 ............................................... 110Costly Registration Requirement Discouraging Clinical Trials in Russia, 12/11 ...................... 111

Association of Clinical Trials Organizations Newsletter #2*Trial Sponsors Urged to Get Early U.S. FDA Approval of PROs, 12/11 .................................. 112

Table of Contents vii

Codependent TechnologiesIndustry Says Combination Technologies Will Need More Tools for Regulation, 1/11 ............ 115

Assessment of Co-dependent Technologies Recommendation 6(e) HTA Review*

Compulsory LicensingIndia — Better Alternatives Exist To Compulsory Licensing, 7/11 .......................................... 119

Conflict of InterestEU Investigating Alleged Fraud, Conflicts of Interest at EMA, 11/11 ......................................123

Contract Manufacturing$64 Billion Market Predicted by 2016 For Pharma Contract Manufacturing, 9/11 ..................127

Corrupt PracticeUK Bribery Act Delayed, Giving Pharma Companies Time to Adjust, 3/11 .............................131

Bribery Act 2010*Drugmakers Hampering U.S. Efforts to Find Tainted Drugs, Agency Says, 12/11 ..................133

FDA Report: Better Coordination Could Enhance Efforts to Address Economic Adulteration and Protect the Public Health*

Counterfeit Medical ProductsCounterfeit Medical Products Under Scrutiny of Medicrime Convention, 1/11 ......................137

Counterfeit Medical Products Under Scrutiny of Medicrime Convention*EU Parliament Approves Law Restricting Counterfeit Products From Market, 3/11 ...............138

Proposal for a Directive of the European Parliament and of the Council Amending Directive 2001/83/EC as Regards the Prevention of the Entry into the Legal Supply Chain of Medicinal Products which Are Falsified in Relation to their Identity, History or Source*

EDQM Moves Forward with Track and Trace System to Fight Counterfeits, 3/11 ..................140EC Adopts Anti-Counterfeit Measure To Secure Supply Chains, 6/11 ....................................141

Directive of the European Parliament and of the Council Amending Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use, as Regards the Prevention of the Entry into the Legal Supply Chain of Falsified Medicinal Products*

Proposal for a Directive of the European Parliament and of the Council Amending Directive 2001/83/EC as Regards the Prevention of the Entry into the Legal Supply Chain of Medicinal Products which Are Falsified in Relation to their Identity, History or Source (first reading)*

viii FDAnews Guide to International Pharma Regulation: 2012 Edition

Global Dragnet Sweeps Up $6.3 Million in Online Counterfeit Meds, 10/11 ...........................143FDA Conducts Preliminary Review of Agency’s Diversion and Counterfeit Criminal Case

Information*

Diabetes DrugsCHMP: Benefits Outweigh Cancer Risk for Pioglitazone Drugs, 8/11 .....................................147

Drug DevelopmentEC Measures Ease Access to Research Grants for Drug Development, 2/11 ............................151

Communication from the Commission to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions Simplifying the Implementation of the Research Framework Programmes*

Key documents for FP7*U.S. Critical Path, EU’s IMI Sign MoU on Medicine Development, 7/11 ................................153Australia Pharma Industry Looks to Senate for Help With PBS Listings, 8/11 ........................154

Submission to the Senate Finance and Public Administration Committee Inquiry into ‘The Government’s Administration of the Pharmaceutical Benefits Scheme’*

EMA: Biomarkers Can Play Role in Drug Development, 9/11 .................................................155Reflection Paper on Methodological Issues Associated with Pharmacogenomic Biomarkers in

Relation to Clinical Development and Patient Selection*NTD Drug Development Outlined In US FDA Draft Guidance, 9/11 .......................................156

Guidance for Industry — Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention*

Pharma Industry Calls for Consistency, Predictability in Health Policies, 9/11 ........................157Xarelto Not Superior to Warfarin To Prevent Strokes: FDA Staff, 9/11 ....................................158Expedited Approval Key to Boosting U.S. Drug Innovation, FDA Says, 11/11 .......................160

Driving Biomedical Innovation: Initiatives to Improve Products for Patients*Britain Plans Major Infusion for Home-Grown Drug Innovation, 12/11 ..................................162

Investing in UK Health and Life Sciences*

Drug RecallsUK’s MHRA to Publish Company-Led Drug Recalls on Website, 4/11 ...................................167

MHRA to Publish Company-Led Drug Recalls*

Drug ResistanceWHO Develops Plan, Requests Help to Prevent Malaria Drug Resistance, 2/11 .....................171

Global Plan for Artemisinin Resistance Containment*

Table of Contents ix

Drug ShortagesU.S. Fabry Patients Petition for Same Fabrazyme Preference as EU, 6/11 ...............................175

Rehearing and Rulemaking Regarding in the Case of Fabrazyme*UK Medicines Shortage Focus of Government Inquiry, 12/11..................................................177

Electronic SubmissionsTGA Releases Guidance for Non-eCTD Electronic Submissions, 1/11 ....................................181

Guidance for Industry on Providing Regulatory Information in Electronic Format: Non-eCTD Electronic Submissions (NeeS) for Human Medicinal Products*

Australia Revamps Electronic Submission Requirements, Requests Comments, 4/11 .............182Electronic Format Requirements for Industry for Providing Regulatory Information Non-

eCTD Electronic Submissions (NeeS) for Human Medicinal Products*EMA Publishes Format for Electronic Submissions for Pharmacovigilance Law, 7/11............183

Detailed Guidance on the Electronic Submission of Information on Medicinal Products for Human Use by Marketing Authorisation Holders to the European Medicines Agency*

Legal Notice on the Implementation of Article 57(2), Second Subparagraph of Regulation (EC) No. 726/2004*

EMA Outlines New Validation Criteria for Electronic Submissions, 9/11 ................................185TIGes Harmonised Guidance for eCTD Submissions in the EU*

Canada Accepting More Drug Submissions in Electronic-Only Format, 10/11 ........................186Update: Increased Scope of Submissions Being Accepted in Electronic Common Technical

Document (eCTD) Electronic-Only Filing Format*

Emerging MarketsIndia’s Pharma Market Expansion Is Prompting Western Interest, 5/11 ...................................189Indian, Uzbekistan MOU Opens Market to Drug Manufacturers, 5/11 .....................................191Czech Republic Offers Budding Market to Biopharma Industry, 7/11 ......................................193Russia to Improve Drug Innovation Through Partnerships, Federal Support, 7/11 ...................194

EnforcementEC Begins Investigating Cephalon, Teva Regarding Provigil Pay-For-Delay Deal, 5/11 .........199U.S. FDA Adapts to Globalization, Reorganizing Compliance Office, 7/11 .............................200New Leader Takes Reins at EMA, 12/11 ...................................................................................202

Fair TradeEU, India Drop WTO Generics Dispute to Enhance FTA Talks, 1/11 .......................................205

Dispute DS408: European Union and a Member State — Seizure of Generic Drugs in Transit*

x FDAnews Guide to International Pharma Regulation: 2012 Edition

Dispute DS409: European Union and a Member State — Seizure of Generic Drugs in Transit*BRICS Countries Boost Access To Drugs Through Collaboration, 8/11 ..................................206

FeesTGA Increases Fees for Drug, Biologic Inclusion on ARTG, 8/11 ...........................................209

Australian Department of Health and Ageing: Summary of Fees and Charges At 1 July 2011*U.S. Drug User Fees to Rise Nearly 20 Percent in October, 8/11 .............................................210

Food and Drug Administration: Prescription Drug User Fee Rates for Fiscal Year 2012*U.S. FDA Sets Redemption Fee for Priority Review Voucher at $5.3 Million, 9/11................. 211French Drugmakers Call Foul on Planned Revenue Tax Hike, 11/11 .......................................212

FinancingSurvey: Canada’s Life Sciences Sector Seeks Funding Support from Government, 2/11 ........217

Inflection Point: Canadian Life Sciences Industry Forecast 2011*Aussie Tax Credit to Attract Global R&D Investments, 9/11 ....................................................218

Generic DrugsCanada’s Generics Industry Expects Increased Costs from EU Proposals, 3/11 .......................223

The Canada-European Union Comprehensive Economic & Trade Agreement: An Economic Impact Assessment of Proposed Pharmaceutical Intellectual Property Provisions*

India, Japan to Share Regulatory Info and Ease Access for Generics, 3/11 ..............................225Comprehensive Economic Partnership Agreement Between Japan and the Republic of India*

Bill Providing Drugs to Third World Divides Canada’s Pharma Industries, 4/11 .....................226BILL C-393: An Act to Amend the Patent Act (Drugs for International Humanitarian

Purposes) and to Make a Consequential Amendment to Another Act*Japan Generic Industry Poised for Growth from Government Support, 4/11 ...........................229

Japanese Generic Market Forecast to 2013*Global Spending on Generics to Skyrocket Worldwide, IMS Says, 6/11 ..................................231

The Global Use of Medicines: Outlook Through 2015 May*Novartis, J&J’s Fentanyl Painkiller Latest Target of EC Antitrust Probes, 11/11 .....................232Generic Drugmakers Get U.S. Guidance on Removing REMS, 12/11 .....................................233

Medication Guides — Distribution Requirements and Inclusion in Risk Evaluation and Mitigation Strategies (REMS)*

Geriatric MedicinesEMA Publishes Strategy on Medicines for Older Population, 3/11 ..........................................237

EMA Geriatric Medicines Strategy*

Table of Contents xi

Effort Under Way in U.S. to Discourage Pay-for-Delay, 12/11 .................................................238Fair and Immediate Release of Generic Drugs Act*

Good Manufacturing PracticeEMA Signs New Cooperation Agreement With International Regulatory Body, 3/11 ..............241

Cooperation Between the Pharmaceutical Inspection Co-operation Scheme and the European Medicines Agency*

Australia Gives GMP Guidance to Overseas Manufacturers, 6/11 ............................................242Australian Regulatory Guidelines Good Manufacturing Practice (GMP) Clearance for

Overseas Manufacturers*Experts Warn U.S., EU Companies To Secure Chinese Supply Chain, 7/11 .............................243U.S. FDA: Overseas Inspections Reveal Recurring, Systemic GMP Issues, 10/11 ..................245Master List Highlighted in Report on Three-Way Collaborative GMP Inspections, 11/11 .......246

Final Report on the International API Inspection Pilot Programme*EMA to Update Qualified Person, Batch Release Requirements, 12/11 ...................................247

Concept Paper on Revising Annex 16 of the Guide to Good Manufacturing Practice: Certification by a Qualified Person and Batch Release*

HarmonizationEU Falsified Medicines Directive Urges Harmonized Safety Features, 7/11 ............................251

Amendment to Directive 2001/83/EC on the Community Code Relating to Medicinal Products for Human Use, as Regards the Prevention of the Entry into the Legal Supply Chain of Falsified Medicinal Products*

International Harmonization Guidance Regulates Annual Drug Safety Reports, 9/11 ..............253Guidance for Industry: E2F Development Safety Update Report*

U.S. FDA Adopts Harmonized Guidance on ICSRs, 11/11 .......................................................254E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation

Guide — Data Elements and Message Specification*Appendix to the ICH E2B(R3) ICRS Implementation Guide: Backwards and Forwards

Compatibility*

Imports, ExportsBrazil, Sweden Agree to Share Medical Products Info, 7/11 .....................................................257US FDA Launches Global Partnerships To Enhance Supply Chain Strategy, 7/11 ...................258

FDA Special Report: Pathway to Global Product Safety and Quality*

InspectionsUS FDA, EMA, TGA to Finalize Joint GMP Inspection Program, 4/11 ...................................263

xii FDAnews Guide to International Pharma Regulation: 2012 Edition

Interim Report on the International API Inspection Pilot Programme*Guidance Outlines Pharma Info Subject to Public Requests, 6/11 ............................................265

HMA/EMA Guidance Document on the Identification of Commercially Confidential Information and Protection of Personal Data*

U.S. FDA, EMA Inspection Pilots Working, Expansion Probable, 8/11 ...................................266Final Report on the International API Inspection Pilot Programme*Report on the Pilot EMA-FDA GCP Initiative*

U.S. Government Watchdog Faults FDA on Overseas Inspections, 10/11 ................................268U.S. GAO Testimony: FDA Faces Challenges Overseeing the Foreign Drug Manufacturing

Supply Chain*

Intellectual PropertyCanadian Generic Firms See Harm in Stronger IP Rights for Brand Companies, 2/11 ............271

Innovation for a Better Tomorrow: Closing Canada’s Intellectual Property Gap in the Pharmaceutical Sector*

LabelingAustralia Seeks Comments on Required Advisory Statements for Drug Labels, 3/11 ..............275

Australian Therapeutic Goods Administration: Required Advisory Statements for Medicine Labels*

New Zealand Changes Bring Rules More in Line with Australia, 8/11 ....................................276January Target for U.S. FDA Safety Labeling Final Guidance, Officials Say, 10/11 ................277EU Clarifies Acceptable Forms of Patient Information on Rx Drugs, 11/11 .............................278

Amended Directive 2001/83/EC, as Regards Information to the General Public on Medicinal Products Subject to Medical Prescription and as Regards Pharmacovigilance*

Macular Degeneration DrugsUK Moves Toward Appraising Avastin as a Cheaper Macular Degeneration Treatment, 1/11 .281

Osteoporosis DrugsReport: Care Trusts Create Range in Access to Osteoporosis Drugs, 2/11 ................................285

Use of NICE-Appraised Medicines in the NHS in England — 2009, Experimental Statistics*Data Quality Statement*

NanotechnologyNanomaterials Still Undefined by EU Experts, Delaying Regulations, 1/11 .............................289

Scientific Basis for the Definition of the Term “Nanomaterial”*

Table of Contents xiii

PackagingIndian Pharma Exports Required to Include Bar Codes on Packaging, 2/11 ............................292EMA Drafts Recommendations on Packaging, Labeling for Non-Prescription Drugs, 5/11 ....293

QRD Recommendations on Pack Design and Labelling for Centrally Authorised Non-prescription Human Medicinal Products*

Bar Codes Due on Indian Drug Exports’ Secondary Packaging, 12/11 .....................................295

Patent ProtectionEU Committee Approves Enhanced Cooperation to Create Patent System, 2/11 .....................298Despite Court’s Opinion on Legal System Work on EU Patent System to Continue, 4/11 .......299

The Draft Agreement on the Creation of a European and Community Patent Court is not Compatible with European Union Law*

EC Submits EU-Wide Patent Proposals, Still Developing Legal System, 5/11 ........................300EU Proposes Legal Strategy in Step Toward Unified Patent System, 7/11 ...............................302

Creating a Unified Patent Litigation System — Orientation Debate*U.S. Patent Reform Bill Ends Fee Diversion, 7/11 ....................................................................304EC Notes Decline in Pay-for-Delay Deals, Closes BI Investigation, 8/11 ................................305Australia, New Zealand Develop Single Patent Application, 8/11 ............................................306U.S. Patent Overhaul Affecting Drugmakers Clears Obama’s Desk, 10/11 ..............................307

Pediatric DrugsEMA: Use of Off-Label, Unauthorized Medicines for Children Needs Attention, 2/11 ........... 311

Report on the Survey of all Paediatric Uses of Medicinal Products in Europe*

Pricing, ReimbursementPoland’s Draft Reimbursement Act Will Impact Pharma Industry, 1/11 ...................................314

Poland’s Draft Reimbursement Act Will Impact Pharma Industry*UK Releases Consultation on Value-Based Drug Pricing, 1/11 ................................................317

A New Value-Based Approach to the Pricing of Branded Medicines: Consultation*Germany Implements Government Control of Pharmaceutical Prices, 2/11 .............................320Greek Pharma Industry Challenged by Government Cuts in Drug Spending, 3/11 ..................321Spanish Pharma Industry Fights for Consistent Countrywide Pricing, 3/11 .............................323AstraZeneca to Settle Multi-Market Tax Issues Through $1.1 Billion Payment, 4/11 ..............325China Prices of 162 Drugs By 21 Percent Possibly Foreshadowing More to Come, 4/11 ........326Australian Govt Delays Drug Listing on PBS, Denying Access to Patients, 5/11 ....................327Pharma Companies Defend Themselves After HIV Drug Pricing Criticism, 8/11 ....................329

xiv FDAnews Guide to International Pharma Regulation: 2012 Edition

UK to Start Value-Based Drug Pricing System Talks Next Year, 8/11 ......................................330A New Value-Based Approach to the Pricing of Branded Medicines: Government Response*

India Drops Bulk Drugs from Pharmaceutical Pricing Policy, 11/11 ........................................331National List of Essential Medicines of India 2011*Draft National Pharmaceuticals Pricing Policy, 2011*

QualityNICE To Create New Quality Standards for 31 Clinical Areas, 1/11 ........................................334

The NHS Outcomes Framework 2011/12*UK’s NICE Prepares for New Role with a New Website Section, 3/11 ....................................335

Safety, Risk ManagementUK Pharma Industry Says Proposed Off-Label Guidance Risks Safety, 7/11 ...........................339

Good Practice in Prescribing and Managing Medicines and Devices*Good Practice in Prescribing and Managing Medicines and Devices: Consultation Response

from the Association of the British Pharmaceutical Industry*EC Draft Guidelines Tighten Supply Chain Requirements, 8/11 ..............................................341

Commission Guidelines on Good Distribution Practice of Medicinal Products for Human Use*

EU Regulators Monitor Radiation In Japanese Manufacturing, 9/11 ........................................342EU’s Updated Annex on Data Controls Stresses Risk Management, 11/11 ..............................343EMA: Toxicological Guidance Needed to Ensure Safety of Drugs Made in Shared Facilities,

11/11 ........................................................................................................................................345Concept Paper on the Development of Toxicological Guidance for Use in Risk Identification

in the Manufacture of Different Medicinal Products in Shared Facilities*

Small BusinessesEuropean SMEs Get Online Registry To Foster Nationwide Partnerships, 1/11 .......................348

Frequently Asked Questions Relating to the Assignment and Maintenance of SME Status by the EMA*

EMA Adds Product Info Through Second Phase of Online SME Register, 4/11 ......................349

TransparencyEuropean Commission to Update Pharma Pricing and Transparency Directive, 4/11 ..............352

Public Consultation on the Possible Revision of Directive 89/105/EEC on the Transparency of Measures Regulating the Pricing and Reimbursement of Medicines*

Council Directive 89/105/EEC Relating to the Transparency of Measures Regulating the

Table of Contents xv

Prices of Medicinal Products for Human Use and their Inclusion in the Scope of National Health Insurance Systems*

Australia’s TGA Extends Transparency Review By Two Months, 5/11 ....................................353Transparency Review Could Threaten Industry Competitiveness, 6/11 ....................................355

Patient Access and Industry Competitiveness at Stake in Transparency Directive Review*EMA Defends Transparency After Calls for Access to Docs, 6/11 ...........................................356Panel: TGA Needs Transparency, Postmarket Process Improvements, 8/11 .............................358

Review to Improve the Transparency of the Therapeutic Goods Administration: Final Report*EMA Database Increases Transparency of European Experts, 10/11 ........................................359

European Medicines Agency Policy on the Handling of Conflicts of Interests of Scientific Committee Members and Experts*

VaccinesWHO Assessment Proves China’s SFDA Meets Vaccine Regulatory Standards, 3/11 .............362U.S. FDA, WHO Working to Improve Regulation of Vaccines, Biologics, 6/11 ......................363

Collaboration in Regulatory Science and Capacity to Advance Global Access to Safe Vaccines and Biologicals*

Japan Grants Funds to Bolster H1N1 Production Capabilities, 9/11 .........................................365U.S. FDA: Cancer Vaccine Trials Should Weigh Impact of Patient Heterogeneity, 11/11 .......366

Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines*

Index by Country/Region/Authority

Index by Issue Date