FDAnews Guide to International PharmaRegulation: 2011 Edition

Table of Contents

Appendices are noted with an asterisk* and can be found in the back of thisbook.

Introduction

Active Pharmaceutical IngredientsEMEA: Drugmakers Must Apply for Changes to APIs, 2/10 . . . . . . . . . . . . . . . . . . . . . . . . . 3

Post-Authorisation Procedural Advice: Human Medicinal Products*Japan Ends Grace Period for Foreign API Makers, 3/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4

China-Japan-Korea Tripartite Cooperation and Japan PMDA’s Perspective onPharmaceutical Quality*

WHO Drafts Guideline on Production, Control of Specified Starting Materials, 5/10 . . . . . . 5Brazil Outlines Requirements for Stability Testing of APIs, 8/10 . . . . . . . . . . . . . . . . . . . . . . 6

Adverse Drug ReactionsChina SFDA 2009 Annual Report Counts 600,000 Adverse Events, 5/10 . . . . . . . . . . . . . . . 9Signal Detection Helps Identify Adverse Events Earlier, 6/10. . . . . . . . . . . . . . . . . . . . . . . . 10EU Parliament Passes Pharmacovigilance Requirement

to Report Adverse Reactions, 10/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Antibacterial DrugsEndpoints, Trial Design for Skin Infection Drugs Are Focus

of US FDA Draft Guidance, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15Guidance for Industry – Acute Bacterial Skin and Skin Structure Infections: Developing

Drugs for Treatment*

Anti-Epileptic DrugsNeed for Pediatric Trials of Anti-Epileptic Drugs Addressed in EMA Guidance, 9/10 . . . . 19

Guideline on Clinical Investigation of Medicinal Products in the Treatment of EpilepticDisorders*

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Antiplatelet Drugs EMA Updates Its Warning on Clopidogrel, PPI Use, 4/10 . . . . . . . . . . . . . . . . . . . . . . . . . . 23

Interaction Between Clopidogrel and Proton-Pump Inhibitors*

AntiviralsUS FDA Minimizing Noninferiority Trials in Guidance on Developing

Direct Antivirals for Hep C, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27Guidance for Industry – Chronic Hepatitis C Virus Infection: Developing Direct-Acting Antiviral Agents for Treatment*

Application, Approval, Authorization, Registration, Regulatory Review MHRA May Allow Needed Drugs to Be Sold Before Approval, 1/10 . . . . . . . . . . . . . . . . . 31

Earlier Access to New Medicines in the UK*UK Marketing Authorization Changes Must Follow EU Regulations, 1/10 . . . . . . . . . . . . . 32

Guideline on the Details of the Various Categories of Variations to the Terms of MarketingAuthorisations for Medicinal Products for Human Use and Veterinary MedicinalProducts*

European Directorate Updates Process for Amending, Renewing CEPs, 2/10 . . . . . . . . . . . 34Procedures for Management of Revisions/Renewals of Certificates of Suitability to the

European Pharmacopoeia Monographs*Guideline on Requirements for Revision/Renewal of Certificates of Suitability to the

European Pharmacopoeia Monographs*New Zealand Proposes Revisions to Medicines Regulations, 3/10 . . . . . . . . . . . . . . . . . . . . 35

Consultation on Proposed Amendments to Regulations Under the Medicines Act 1981*EU, FDA Question J&J Trials, Zeftera Withdrawn from Canada, 4/10. . . . . . . . . . . . . . . . . 37Multi-Site Manufacturing Licenses Subject to TGA Criteria, 4/10 . . . . . . . . . . . . . . . . . . . . 38

Therapeutic Goods (Multi-Site Manufacturing) Licenses Guidelines of 2010*Canada Plans New Submission Route for Extraordinary Use New Drugs, 5/10 . . . . . . . . . . 39

Regulations Amending the Food and Drug Regulations (1319 – New Drugs forExtraordinary Use)*

US FDA Creates New Division to Address ANDA Backlog, 6/10 . . . . . . . . . . . . . . . . . . . . 41Australian PARs on Prescription Drugs to Include Product Information, 7/10 . . . . . . . . . . . 42

TGA Australian Public Assessment Report (AusPAR) for Prescription Drugs – GuidanceDocument Version 1.2*

Philippines Creates Its Own FDA to Tighten Regulation of Drugs and Devices, 8/10 . . . . . 43The Rules and Regulations Implementing Republic Act No. 9711, the Food and Drug

Administration Act of 2009*Australia’s TGA Set to Implement More Streamlined Review Process

for Pharmaceuticals, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

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MHRA Audit: One-Third of Variations Notices Denied Under New EU Regulations, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 46

Singapore Issues Guidance for Abridged Evaluation of New Drug Applications, 10/10 . . . 47Guidance on Medicinal Product Registration in Singapore*

India Outlines Requirements for CTDs in New Drug Applications, 11/10 . . . . . . . . . . . . . . 49Guidance on Clinical Trial Inspection*

TGA Lists Requirements for Submissions Under Streamlined Drug Review Process, 11/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

Drugmakers Will Have Increased Say in British Columbia Review Process, 12/10 . . . . . . . 52US FDA Promises Less Assistance for Drug Name Review Process, 12/10 . . . . . . . . . . . . . 53

Guidance for Industry – Contents of a Complete Submission for the Evaluation ofProprietary Names*

Asthma DrugsUS FDA Issues Final Rule, Extends Deadline for ODS Inhaler Ban, 5/10 . . . . . . . . . . . . . . 57

Use of Ozone-Depleting Substances: Removal of Essential Use Designation (Flunisolide,etc.)*

Bioequivalence TestingBioequivalence Study Requirements Outlined in New EMEA Guidance, 2/10. . . . . . . . . . . 61

Guideline on the Investigation of Bioequivalence*

BiologicsHealth Canada Issues Draft Guidance on Follow-On Biologics, 3/10 . . . . . . . . . . . . . . . . . . 65

Guidance for Sponsors – Information and Submission Requirements for Subsequent EntryBiologics (SEBs)*

US FDA Proposes Biologics Rule to Ease Restrictions on Constituent Materials, 4/10 . . . . 66Proposed Rule: Revision of the Requirements for Constituent Materials*

Australia Would Separate Biologicals Regulatory Regime from Drugs, 5/10 . . . . . . . . . . . . 67Therapeutic Goods Amendment (2009 Measures No. 3) Bill 2009*

Australia Amends Regulations to Include Biologics Framework, 12/10 . . . . . . . . . . . . . . . . 68Proposed Amendments to the Therapeutic Goods Regulations 1990 to Implement the

Biologicals Framework*

BiosimilarsNICE Suggests First Biosimilar for the UK Market, 6/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . 71Biosimilar Drug Developers Told to Be Patient as US FDA Develops

Regulatory Framework, 7/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72US FDA Schedules First Public Meeting on Biosimilars Pathway, 10/10. . . . . . . . . . . . . . . 74

Approval Pathway for Biosimilar and Interchangeable Biologic Products*

EMA Reducing Regulatory Burden for Sponsors of MAb Biosimilars, 12/10 . . . . . . . . . . . 76Guideline on Similar Biological Medicinal Products Containing Monoclonal Antibodies*

Cancer DrugsCanada Ranks Next to Last in Access to Cancer Drugs, Report Prompts Call for Canadian

Cancer Drug Fund, 8/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Extent and Causes of International Variations in Drug Usage*

Analysis: Cancer Drugs Face Most Difficulty Gaining Approval from NICE, 9/10 . . . . . . . 82EMA May Revise Guidance on Cancer Drug Trials to Harmonize

with Recent Appendices, 10/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 83Concept Paper on the Need to Revise the Guideline on the Evaluation of Anticancer

Medicinal Products in Man*

Clinical TrialsEMEA Outlines Requirements for GERD Drug Studies, 1/10. . . . . . . . . . . . . . . . . . . . . . . . 87

Draft Guideline on the Evaluation of Drugs for the Treatment of Gastroesophageal RefluxDisease*

US May Require Subject Consent to Clinical Trial Listings, 1/10. . . . . . . . . . . . . . . . . . . . . 88Informed Consent Elements*

EMEA Adopts Clinical Trial Guidelines for Drugs to Treat Epileptic Disorders, 2/10 . . . . 89Guideline on Clinical Investigation of Medicinal Products in the Treatment of

Epileptic Disorders*Osteoarthritis Drug Development Is Focus of EMEA Guidance, 2/10 . . . . . . . . . . . . . . . . . 90US FDA Issues Draft Guidance on Noninferiority Studies, 3/10. . . . . . . . . . . . . . . . . . . . . . 91

Guidance for Industry – Non-Inferiority Clinical Trials*FDA Draft Guidance Recommends PK Studies for Some Patients, 4/10 . . . . . . . . . . . . . . . 93

Guidance for Industry – Pharmacokinetics in Patients with Impaired Renal Function —Study Design, Data Analysis and Impact on Dosing and Labeling*

EU Outlines Process for Submitting Results-Related Data to EudraCT, 6/10 . . . . . . . . . . . . 94Implementing Technical Guidance – List of Fields for Results-Related Information to Be

Submitted to the ‘EudraCT’ Clinical Trial Database*NIH Rule Sets Lower Threshold for Disclosure Requirements, 6/10 . . . . . . . . . . . . . . . . . . 95

Responsibility of Applicants for Promoting Objectivity in Research for Which PublicHealth Service Funding is Sought and Responsible Prospective Contractors*

US FDA: IND Optional for Foreign Sites Included in Multicountry Study, 6/10 . . . . . . . . . 97Information Sheet Guidance for Sponsors, Clinical Investigators and IRBs: Frequently

Asked Questions—Statement of Investigator (Form FDA 1572)*US FDA Proposes to Extend Investigator Disqualification Agencywide, 6/10 . . . . . . . . . . . 98

Guidance for Institutional Review Boards, Clinical Investigators and Sponsors – ClinicalInvestigator Administrative Actions—Disqualification*

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China’s SFDA Clinical Trial Approvals Process Requires Translation, Attention toRequirements, 7/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

International Drug Industry Group Wants All Phase III Results Published, 7/10 . . . . . . . . 101Study: Burdensome Regulation Creates Barrier for Investigators, 7/10. . . . . . . . . . . . . . . . 102US HHS Inspector General Finds Monitoring of Overseas Clinical Trials Lax, 7/10 . . . . . 103

Challenges to FDA’s Ability to Monitor and Inspect Foreign Clinical Trials*Canadian Regulation, Safety Measures Stifling Clinical Research, Experts Say, 8/10 . . . . 105Challenge of EU Clinical Trials is Navigating Privacy Rules, 8/10. . . . . . . . . . . . . . . . . . . 106EMA Guidance on Electronic Clinical Trial Data Requires Certified Copies

Prior to Transfer, 9/10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108European Medicines Agency Guidance on the Use of Electronic Data in Clinical Trials*

US FDA Draft Guidance Proposes Asking Trial Subjects Questions About Suicidality, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110US FDA Guidance on Suicidality Determinations in Clinical Trials*

Industry to EMA: Allow Preapproval of NIMPs Used in Clinical Trials, 10/10 . . . . . . . . . 112Sponsors Should Identify Methods to Avoid Missing Data in Trials, 10/10 . . . . . . . . . . . . 113

European Medicines Agency Guideline on Missing Data in Clinical Trials*US Government Apologizes for Intentionally Infecting Guatemalans in 1940s STD

Study, 10/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 114EMA Guidance Addresses Individual Case Safety Reports for Clinical Trials, 11/10 . . . . 116

Guidance – EudraVigilance Human: Processing of Safety Measures and Individual Case Safety Reports (ICSRs)*

Implementation Plan – EudraVigilance Human: Processing of Safety Messages andIndividual Case Safety Reports (ICSRs)*

US FDA Draft Guidance Offers Exceptions for Clinical Trials, 11/10 . . . . . . . . . . . . . . . . 117Guidance for Industry – Investigational New Drug Applications (NDAs) —

Determining Whether Human Research Studies Can Be Conducted Without an IND*ENCePP Compiles Guide of International Standards for Clinical Study Design, 12/10 . . . 118

ENCePP Guide on Methodological Standards in Pharmacoepidemiology*Checklist of Methodological Research Standards for ENCePP Studies*

Codependent TechnologiesAustralia Releases Consultation Regarding Appraisals

of Codependent Technologies, 11/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123Draft Information Requests for Assessing a Pair of Co-Dependent Technologies*

Compassionate UseEMEA Grants First Early Approval Under Compassionate Use Program, 2/10 . . . . . . . . . 127

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Compulsory LicensingIndia Considering Compulsory Licensing for Drugs, Seeking Input on Improving Drug

Availability, 9/10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131

Confidential Information ExchangeEMA: ‘Lite’ Confidentiality Pacts Could Reduce Industry Burden, 4/10 . . . . . . . . . . . . . . 135Brazil, China Strengthen Ties on Healthcare Regulation, 6/10 . . . . . . . . . . . . . . . . . . . . . . 136US FDA, CMS Will Protect Trade Secrets Under Information-Sharing MOU, 8/10 . . . . . 137

Memorandum of Understanding Between United States Food and Drug Administration andCenters for Medicare & Medicaid Services*

EMA, US FDA Agree to Extend Indefinitely Confidential Information Agreement, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139Statement of Authority and Confidentiality Commitment from the European Medicines

Agency Not to Publicly Disclose Non-Public Information Shared by the United StatesFood and Drug Administration*

Conflict of InterestIndia Strengthens Ethics Regulations for Drugmakers, Physicians, 1/10. . . . . . . . . . . . . . . 143EMA Adopts Risk-Based Policy for Scientists’ Conflict of Interest, 11/10 . . . . . . . . . . . . 144

European Medicines Agency Policy on Conflict of Interest*

Corrupt PracticeUS Authorities Investigate Foreign Activities of Big Pharma

for Corrupt Practices, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147Australian Trade Group Fines Drugmakers for Misleading Claims,

Code of Conduct Breach, 11/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148Medicines Australia Code of Conduct Quarterly Report July-September 2010*

Counterfeit Medical ProductsTo Protect Against Counterfeits, Industry Should Watch Internet, 3/10 . . . . . . . . . . . . . . . 153US FDA, WHO to Develop Surveillance and Monitoring System to Stop

Counterfeits, 10/10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 155International Sting Nets $2.6 Million in Online Counterfeit Drugs, 11/10 . . . . . . . . . . . . . 156US Lawmakers Voice New Concerns Over Anti-Counterfeiting

Trade Agreement, 11/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 158

Diabetes DrugsEMEA Advises Diabetes Trial Sponsors to Review Cardiovascular Risk, 2/10 . . . . . . . . . 161

Guideline on Clinical Investigation of Medicinal Products in the Treatment of DiabetesMellitus*

US FDA to Combine Two Diabetes Drug Development Guidances, 11/10 . . . . . . . . . . . . 162

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Drug DevelopmentUS FDA Seeks Sponsor Comment on Drug Co-Development, 6/10 . . . . . . . . . . . . . . . . . . 165

Investigational New Drug Applications: Co-Development of Investigational Drugs*Canada Reports Decline in Drug R&D Spending, 7/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

Patented Medicines Pricing Review Board Annual Report 2009US FDA Draft Guidance Explains New Drug Development Tools, 11/10 . . . . . . . . . . . . . 168

Guidance for Industry – Qualification Process for Drug Development Tools*

Electronic SubmissionsEMA Asks Drugmakers to Use eSubmissions for Parallel Distribution Notices, 9/10 . . . . 171

Guideline for the Specifications of e-Submissions of Parallel Distribution NotificationDocuments*

Guidance on the Centrally Authorised Products Requiring a Notification of a Change forUpdate of Annexes*

Emerging MarketsRegulatory Barriers Accompany Emerging Markets Growth, 4/10 . . . . . . . . . . . . . . . . . . . 175IMS: Global Drug Sales Will Rise in 2011, Driven by Emerging Markets, 10/10 . . . . . . . 176Chinese, US Trade Associations Sign Cooperative Framework, 12/10 . . . . . . . . . . . . . . . . 177

EnforcementMHRA Expands Enforcement Toolkit for Pharmaceutical, Device Companies, 7/10 . . . . 181US OIG Has Authority to Exclude Biopharma Officers, Management

from Medicare, 11/10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 182Guidance for Implementing Permissive Exclusion Authority Under Section 1128(b)(15) of

the Social Security Act*

Fair TradeUN: Colombia Fair Trade Pact Would Limit Drug Access, 6/10. . . . . . . . . . . . . . . . . . . . . 187EU-South Korea Trade Pact Will Increase Access to Drugs, 10/10. . . . . . . . . . . . . . . . . . . 188

FeesEMEA Changes Fees for Variations to Marketing Authorizations, 1/10 . . . . . . . . . . . . . . . 191

EMEA Explanatory Note on Marketing Authorization Fee*Canada Proposes Higher User Fees to Help Cover Increased Workload, 5/10 . . . . . . . . . . 192

Fixed Dose CombinationsIndia Launches Consultation on Fixed-Dose Combinations

Including Investigational Drugs, 9/10. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 195Guidance for Industry on Fixed-Dose Combinations (FDC)*

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Generic DrugsEC Further Expands Investigation into Market Delays of Generics, 1/10 . . . . . . . . . . . . . . 199Generic Sponsor CRO Oversight to Be Tested by EMA Program, 3/10 . . . . . . . . . . . . . . . 200All Canada Watching Ontario’s Plan to Reform Generic Drug System, 5/10 . . . . . . . . . . . 201Brazil, India Gain Headway in Defense of Generics, 6/10. . . . . . . . . . . . . . . . . . . . . . . . . . 203Ontario Approves Generic Drug Price-Slashing Scheme, 6/10 . . . . . . . . . . . . . . . . . . . . . . 205British Columbia Outlines Plan to Lower Generic Drug Prices, 7/10 . . . . . . . . . . . . . . . . . 206UK Drops Plans for Generic Substitution of Primary Care Drugs

by Pharmacists, 11/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 208

Good Manufacturing PracticeTGA Gives Drugmakers Guidance on Nonsterile Drug Supply Chain, 3/10. . . . . . . . . . . . 213

Technical Guidance on the Interpretation of Manufacturing Standards: Supplier Qualification*Technical Guidance on the Interpretation of Manufacturing Standards: Process Validation

for Listed Complementary Medicines*New Drug Manufacturing Principles Go into Effect in Australia, 7/10 . . . . . . . . . . . . . . . . 214Manufacturers Sought for Joint US FDA, EMA GMP Inspection Pilot, 8/10 . . . . . . . . . . . 215

EMA/FDA Joint GMP Inspection Pilot Program: General Principles*EMA/FDA Joint GMP Inspection Pilot Program: Terms of Reference and Procedures for

Participating Authorities (Manufacturers of Medicinal Products)*China Aligns Drug GMP with Global Standards, US FDA, Drugmakers

Applaud Move, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 217EC Updates GMP Guide to Include Outsourced Activities for Drugs, 12/10 . . . . . . . . . . . 218

Good Manufacturing Practice Chapter 7: Outsourced Activities*US FDA Revising GMP Regulations to Require Audits

of Raw Material Suppliers, 12/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

HarmonizationUS FDA Implements ICH Guidance on Advanced-Cancer Drug Trials, 3/10. . . . . . . . . . . 223

Guidance for Industry – S9 Nonclinical Evaluation for Anticancer Pharmaceuticals*US FDA Adopts ICH’s Standards on Friability, Dissolution Tests, 4/10 . . . . . . . . . . . . . . 224

Guidance for Industry – Q4B Annex 9: Tablet Friability General Chapter*Guidance for Industry – Q4B Annex 7: Dissolution Test General Chapter*Guidance for Industry – Q4B Annex 10: Polyacryalamide Gel Electrophoresis General Chapter*

US FDA Draft Guidance Harmonizes Powder Density Texts with ICH, 8/10 . . . . . . . . . . 226Guidance for Industry – Q4B Annex 13: Bulk Density and Tapped Density of Powders

General Chapter*US FDA, PAHO Agreement Could Enhance Regulatory Harmonization, 10/10 . . . . . . . . 227

Cooperative Agreement with the Pan American Health Organization for the Developmentof an Information Hub for Medical Products and Related Regulatory Processes andSystems in the Americas Region*

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Imports, ExportsOverruling of US FDA Import Decision May Be Opportunity for Drugmakers, 2/10 . . . . 231US FDA Expands PREDICT System to Ensure Safety of Drug Imports, 3/10 . . . . . . . . . . 232US FDA’s PDUFA Reauthorization Process Focuses on Import Drug Safety, 5/10 . . . . . . 233Proposed US Bill Could Be Burden for Some Foreign Drugmakers, 7/10 . . . . . . . . . . . . . 234

Foreign Manufacturers Legal Accountability Act of 2010*US FDA Overseas Offices Should Improve Coordination, Planning for Import

Safety, 11/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 236Food and Drug Administration: Overseas Offices Have Taken Steps to Help Ensure Import

Safety, but More Long-Term Planning Is Needed*

InfluenzaUS FDA Guidance Details Emergency Production Plans, 1/10 . . . . . . . . . . . . . . . . . . . . . . 241

InspectionsEMA Clarifies Requirements for Impurities, Stability, 4/10 . . . . . . . . . . . . . . . . . . . . . . . . 245US FDA to Begin Part 11 Inspections to Deal with Compliance Issues, 7/10. . . . . . . . . . . 246

Guidance for Industry – Part 11 Electronic Records; Electronic Signatures—Scope andApplication*

Initial Results Released on Three-Way GMP Inspection Pilot, 10/10 . . . . . . . . . . . . . . . . . 247European Medicines Agency Interim Report on the International API Pilot Programme*

US Lawmakers Want to Give FDA Broader Powers for Foreign Activities, 10/10 . . . . . . 248Discussion Draft to Amend the Federal Food, Drug and Cosmetic Act to Improve the

Safety of Drugs, and for Other Purposes*EMA: US FDA Cooperation Spurred Inspections Activity in 2010, 11/10 . . . . . . . . . . . . . 249

European Medicines Agency Mid-Year Report 2010 (January – June 2010)*

US FDA Foreign Inspections Better but Still Lag Behind Domestic, 11/10 . . . . . . . . . . . . 250Drug Safety: FDA Has Conducted More Foreign Inspections and Begun to Improve Its

Information on Foreign Establishments, but More Progress is Needed*

Intellectual PropertyEuropean Council Streamlines New Patent Court System, 1/10 . . . . . . . . . . . . . . . . . . . . . 255UK Appeals Court: Gene Sequence Needs Specific Application to Be Patentable, 2/10 . . 256

England and Wales Court of Appeal (Civil Division) Decisions: Ely Lilly & Company v.Human Genome Sciences Inc.*

Problematic Patent Settlements Declining in EC Countries, 7/10 . . . . . . . . . . . . . . . . . . . . 2571st Report on the Monitoring of Patent Settlements (period mid 2008 – end 2009)*

US Supreme Court Bilski Decision Could Aid Drugmakers Seeking Patents, 7/10 . . . . . . 258Bilski et al. v Kappos, Under Secretary of Commerce for Intellectual Property and

Director, Patent and Trademark Office*

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LabelingEU Considers Rule on Providing Drug Information to Patients, 4/10 . . . . . . . . . . . . . . . . . 261

Draft Report on the Proposal for a Directive of the European Parliament and the CouncilAmending, as Regards Information to the General Public on Medicinal Products Subjectto Medical Prescriptions, Directive 2001/83*

Health Canada Updates Labeling for Drugs in Draft Guidance, 8/10 . . . . . . . . . . . . . . . . . 262Draft Guidance – Labeling of Pharmaceutical Drugs for Human Use*

UK Drug Labeling Changes Come into Effect in October, 8/10 . . . . . . . . . . . . . . . . . . . . . 263

Lupus DrugsUS FDA Offers Final Guidance on Developing Drugs for Lupus Erythematosus, 7/10 . . . 267

Guidance for Industry – Lupus Nephritis Caused by Systemic Lupus Erythematosus —Developing Medical Products for Treatment*

NanotechnologyDrugmakers Await New US FDA Guidance, Consensus Standards on

Nanotechnology, 9/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 271

Orphan Medical ProductsEMEA Checklist Helps Drugmakers Transferring OMP Designations, 2/10 . . . . . . . . . . . 275

Checklist for Sponsors Applying for the Transfer of Orphan Medicinal Product (OMP)Designation*

EMEA, US FDA Simplify Submission of Annual Updates for Orphan Drugs, 3/10 . . . . . 276NHS Pilot Program Grants Orphan Drug Access, 4/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277

Consultation Response on Proposals for an Innovation Pass Pilot*Orphan Drug Designation Requests in EU Increase 38 Percent in 2009, 6/10 . . . . . . . . . . 278

EMA Annual Report 2009*EMA Guidance Sets Out Requirements for Orphan Drug Designation, 8/10 . . . . . . . . . . . 279

Recommendation on Elements Required to Support the Medicinal Plausibility and the Assumption of Significant Benefit for an Orphan Designation*

Health Canada Seeks Input on Possible Orphan Drug Policy, 10/10 . . . . . . . . . . . . . . . . . . 280UK Physicians: Makers of Orphan Drugs Limit Competition, Charge Too Much, 12/10. . 281

PackagingTGA Seeks to Expand Requirements for Child-Resistant Packaging, 2/10 . . . . . . . . . . . . . 285

Proposed Amendments to Therapeutic Goods Order No. 80 – Child-Resistant PackagingRequirements for Medicines (TGO 80)*

US FDA Guidance Specifies SNIs to Authenticate Drug Packages, 4/10 . . . . . . . . . . . . . . 286Guidance for Industry – Standards for Securing the Drug Supply Chain—Standardized

Numerical Identification for Prescription Drug Packages*

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Pediatric DrugsEMEA Updates Application Process for Pediatric Products, 1/10 . . . . . . . . . . . . . . . . . . . . 289EU Pediatric Research Network to Launch in Second Half of 2010, 6/10 . . . . . . . . . . . . . 290

Report on Second Workshop of the European Pediatric Research Network, 16 March 2010*Criteria for the Recognition of an Investigator, Site or Network as a Member Of the

EnprEMA*

Postmarket Report, SurveillanceUS FDA Draft Guidance Lists Postapproval CMC Changes Permitted in Annual

Reports, 7/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 293Guidance for Industry – CMC Postapproval Manufacturing Changes Reportable in Annual

Reports*

Premenstrual Dysphoric DisorderEMA Outlines Requirements for PMDD Drug Trials, 6/10 . . . . . . . . . . . . . . . . . . . . . . . . . 297

Guideline on the Treatment of Premenstrual Dysphoric Disorder (PMDD)*

Pricing, ReimbursementGermany’s Drug Price Proposal Draws Ire of Merck Chairman, 4/10. . . . . . . . . . . . . . . . . 301Australian Drugmakers See Price Cuts as Key to Future Economic Stability, 5/10 . . . . . . 302Canadian Provinces Sign Deal to Pool Purchases of Medical Supplies, 6/10 . . . . . . . . . . . 303

New West Partnership*United Kingdom Considers a Move to Value-Based Drug Pricing, 6/10. . . . . . . . . . . . . . . 304Canadian Study: Drug Price Controls Don’t Benefit Consumers, 7/10 . . . . . . . . . . . . . . . . 306Tufts: US Could Benefit from Greater Evidence-Based Reimbursement, 7/10 . . . . . . . . . . 307Study Equates Pricing Regulations with Drop in Drug Innovation, 7/10. . . . . . . . . . . . . . . 308Germany’s Drug Pricing Reforms Legislation Moves to Parliament, 8/10 . . . . . . . . . . . . . 310UK Government’s NHS Reform Plan Includes Shift to Value-Based Pricing, 8/10 . . . . . . 312New Zealand Adds Pfizer’s Champix to Smoking Cessation Arsenal, 11/10 . . . . . . . . . . . 313Committee Recommends Doubling Threshold for Australia Pharma

Benefits Service, 12/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 314Consumer Access to Pharmaceutical Benefits*

EU to Spain: End Discounted VAT for Drug Components and Devices, 12/10 . . . . . . . . . 316Council Directive 2006/112/EC of 28 November 2006 on the Common System of Value

Added Tax*Legislation in Germany Moves Country Toward Pharmaceutical Price Controls, 12/10 . . 317

Executive Summary of the VFA’s Position on the Act for the Restructuring of thePharmaceutical Market in Statutory Health Insurance (AMNOG)*

xiv FDANEWS GUIDE TO INTERNATIONAL PHARMA REGULATION: 2011 EDITION

Product LiabilityCanadian Court Ruling May Lead Pfizer to Consider Neurontin Appeal, 4/10. . . . . . . . . . 321

RadiopharmaceuticalsUS Guidance Outlines Submissions for Contrast Imaging Indications, 1/10. . . . . . . . . . . . 325

Guidance for Industry – New Contrast Imaging Indication Considerations for Devices andApproved Biological Products*

US FDA Expects Global Shortage of Radiopharmaceutical Drug, 2/10 . . . . . . . . . . . . . . . 326US Radioactive Drug Guidance Draws Line Between Basic Human, Clinical

Research, 8/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327Guidance for Industry and Researchers – The Radioactive Drug Research Committee:

Human Research Without an Investigational New Drug Application*

Regulatory ScienceEMA, MIT Join Together to Research Pharma Regulatory Science, 12/10. . . . . . . . . . . . . 331

Safety, Risk ManagementExpert Advice on Drug Safety to Be Offered by Committee, 4/10 . . . . . . . . . . . . . . . . . . . 335China SFDA Issues Provisions for Drug Precursor Chemicals, 5/10. . . . . . . . . . . . . . . . . . 336US FDA’s Foreign Offices Increasing Collaboration with Regulators, Industry, 7/10 . . . . 337France Amends Drug GMP Rules to Address Risk Management, 8/10. . . . . . . . . . . . . . . . 338Health Canada Outlines Procedures for Public Safety Alerts, 8/10 . . . . . . . . . . . . . . . . . . . 339

Guidance for Industry – Issuance of Health Professional Communications and PublicCommunications by Market Authorization Holders*

Abbott Withdraws Meridia from Australian, Canadian, US Markets, 10/10 . . . . . . . . . . . . 340

Scientific Advice ProgramMHRA Develops Pilot with NICE, Offers Parallel Scientific Advice, 5/10 . . . . . . . . . . . . 343

Site Master FilesSaudi Arabia Gives Instructions for Site Master Files, 1/10 . . . . . . . . . . . . . . . . . . . . . . . . 347

Guidance for the Preparation of a Site Master File (SMF)*

Small BusinessesEU Supports Small European Drugmakers in Accessing the Chinese Market, 12/10 . . . . . 351

Centre for European Union Small and Medium Enterprises*

Technology AssessmentNICE Outlines Appeals Process for Drug Determinations, 1/10 . . . . . . . . . . . . . . . . . . . . . 355

The Technology Appraisal Appeal Process*

NICE Turns Down Cancer Drugs for Lack of Cost-Benefit, 2/10 . . . . . . . . . . . . . . . . . . . . 356Roche’s MabThera Recommended by NICE When TNF Inhibitors Fail, 3/10 . . . . . . . . . . 358

Rheumatoid Arthritis – Drugs for Treatment After Failure of a TNF Inhibitor*Canada Rejects Majority of New Drugs Based on Evaluation of Other HTAs, 5/10 . . . . . 359New Role for NICE: Incremental Benefits Evaluation, Assessment, 11/10 . . . . . . . . . . . . 361Ireland Targets Cost-Effectiveness in Its New Assessment Guidelines, 12/10 . . . . . . . . . . 362

Guidelines for the Economic Evaluation of Health Technologies in Ireland*Guidelines for Budget Impact Analysis of Health Technologies in Ireland*

Transdermal Drug DeliveryUS FDA Guidance on Transdermal Patches Suggests Way to Minimize Residual

Drug, 8/10 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 365Guidance for Industry – Residual Drug in Transdermal and Related Drug Delivery

Systems*

TransparencyExperts: More Transparency Needed in EMA New Drug Approval Process, 4/10 . . . . . . . 369EU Ombudsman Asks EMA to Improve Transparency, 5/10 . . . . . . . . . . . . . . . . . . . . . . . 370

Draft Recommendation of the European Ombudsman in His Inquiry into Complaint2493/2008 (BB)TS Against the European Medicines Agency*

EU Seal Designates Transparent Postmarket Drug Studies, 6/10. . . . . . . . . . . . . . . . . . . . . 371TGA Is Reviewing Its Communications to Improve Regulatory Transparency, 12/10 . . . . 372

VaccinesViral Vaccine Makers Get Guidance from US FDA Outlining Procedures, 3/10 . . . . . . . . 375

Index by Country/Region/Authority

Index by Issue Date

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