INTERNATIONAL PHARMACEUTICAL REGISTRATION

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1 INTERNATIONAL PHARMACEUTICAL REGISTRATION Edited by Alan A. Chalmers INTERPHARM PRESS Interpharm Press Denver, Colorado

2 Contents INTRODUCTION xv EDITOR BIOGRAPHY xvii AUSTRALIA 1 Carmen Langley Country Description 2 An Overview of the Regulatory Environment 4 Regulatory Authorities 9 Regulatory Requirments and Procedures 15 Orphan Drugs 22 Future Trends 22 References 23 About the Author 24 Glossary BELGIUM 27 Leo Vervoort Definition of a Medicine 28 The Medicines Commission 28 Registration Procedure 30 Refusing, Suspending or Revoking Registration 38 Post Registration 42 iii

3 iv International Pharmaceutical Registration Price and Reimbursement Procedures 43 Reimbursement 44 Promotion and Advertising 45 Adverse Drug Reactions 46 Inspections 47 Samples 48 A New Medicines Institute 48 An Overview of the Most Important Laws 49 References 50 About thie Author 51 BRAZIL 53 Paulette Lopes Overview of Regulatory Affairs 53 About the Author 56 BULGARIA 57 Jasmina Mircheva Country Description 57 Overivew of Regulatory Environment and Background 59 Regulatory Authorities 62 Regulatory Requirements and Procedures 62 Future Trends 67 Acknowledgments, 67 About the Author 67 Chapter Appendices 69 CANADA ' 83 John P. Gams Food and Drugs Act 84 Part C in Drug Regulations Division 1 85 Establishment Licences Division 1A 86 Good Manufacturing Practices (GMP) 87 Schedule C Drugs Division 3 89 Schedule D Drugs Division 4 91 Canadian Standard Drugs Division 92 New Drugs Division 8 92

4 Contents v Non-Prescription Drugs Division 9 97 Proprietary Medicine Division About the Author 99 EUROPEAN UNION 101 David Lyons National Registration 103 The Decentralised Procedure 103 Mutual Recognition Procedures (MRP) 104 Making the MRP Work 105 Centralised System 106 Conclusion 106 About the Author 107 FRANCE 109 Marie-Daniele Campion Country Description 109 Social Security 111 Reform of Medical Matters 112 Overview of Regulatory Environment/Background 113 Regulatory Authorities 114 Requirements ' 118 Future Trends 124 Abbreviations 129 References 130 About the Author 131 GERMANY ' 133 Dieter Zeppenfeldt Country Description 134 Overview of Regulatory Environment and Background 134 Regulatory Authorities 135 Regulatory Requirements and Procedures 136 Future Trends 143 About the Author 144

5 yi International Pharmaceutical Registration GULF STATES 145 Louis Adhihetty Location, Area, Population and Funds 145 Pharmaceutical Market 146 Regulatory Requirments 149 Current and Future Developments 166 References 168 Acknowledgments 169 About the Author 169 HUNGARY 171 Tamds L. Padl Country Description 172 Overview of Regulatory Environment Until Late 1990s 173 Overview of the Recent Regulatory Environment 177 Regulatory Authorities 180 Regulatory Requirements and Procedures 181 Practical Aspects 188 Future Trends ' 188 References 189 About the Author 191 INDIA 193 Harish Bolar and Arun Bhatt Regulatory Laws 193 Schedules 194 Registration of New Drugs 195 Four-Year Stipulation, 196 Requirements for Registration 196 Regulatory Environment and Practices 199 Manufacturing Options 200 Current Developments 200 Advertisement of Drugs 201 Pricing of Drugs 201 Other Laws 201 Conclusion 203 References 203 About the Author 203

6 Contents vii IRELAND 205 David Lyons Abbreviations and Nomenclature 205 Introduction 206 Economy 206 The Pharmaceutical Industry in Ireland 206 Overview of the Regulatory Environment 207 Structure and Function of the Board 207 Licensing Activities 209 Relationships with the European Medicines Evaluation Agency 209 Medical Devices 209 Clinical Trials 209 Assessment and Authorisation Process 210 Variations 212 Renewals 212 Rejection Procedure 212 Fee Structure 213 Future Trends 215 About the Author 217 Chapter Appendix 218 ISRAEL 219 Simon Dusseldorp Country Description 221 Overview of Regulatory Environment/Background 224 The Authorities 226 Pharmacists' Regulations (Medicinal Products) 1986 ' 228 Pharmaceutical Registration Approach and Policy Specific Issues 230 The Registration Process: Requirements and Procedures 232 Fees 239 Generic Product Registration/Bioequivalence Studies 239 Labeling and Consumer Information 241 Clinical Research 242 Regulation of Other Categories 244 Future Trends 246 Acknowledgment j 246 About the Author 246 Chapter Appendices 247

7 viii International Pharmaceutical Registration JAPAN 261 Takashi Takahashi Country Description 262 Overview of Regulatory Environment/Background 263 Regulatory Authority 269 Regulatory Requirements and Procedures 270 Future Trends 312 References 313 About the Author 313 Chapter Appendix 314 REPUBLIC OF KOREA 321 Alan A. Chalmers Country Description 321 Overview of Regulatory Envirionment/Background 322 Regulatory Authorities 323 Regulatory Requirements and Procedures 323 Registration Procedures 326 Practical Aspects 329 Future Trends 330 Acknowledgment * 330 About the Author 331 MALAYSIA 333 Anis Ahmad Country Description 333 Overview of the Regulatory Environment 335 Regulatory Authorities 338 Requirements and Procedures for Registration 340 Future Trends 348 About the Author 349 THE NETHERLANDS 351 Peter J. Reijnders Country Description 351 Overview of Regualtory Environment/Background 352

8 Contents ix Regulatory Authorities 358 Regulatory Requirements and Procedures 362 Miscellaneous 372 Future Trends 377 References 378 About the Author 378 NEW ZEALAND 381 Mike Thompson Country Description 382 Therapeutic Products Legislation 384 Regulatory and Funding Authorities 392 Regulatory Requirements and Procedures 398 Future Trends 410 Reference Table 412 Acknowledgments 412 About the Author 412 Chapter Appendices, 413 NIGERIA 421 J EbenezerO. Ogunlana Country Description 423 Regulatory Authorities 430 Regulatory Requirements and Procedures 434 Future Trends 444 References 449 About the Author 451 p POLAND 453 Joanna Kielanowska Country Description and History 454 Background of Regulatory Environment 461 Fees 464 Regulatory Authorities 466 Bureau of Drug and Medical Devices Registration (BODMDR) 468 Regulatory Requirements and Procedures 470 Future Trends 483 About the Author 485

9 x International Pharmaceutical Registration PORTUGAL 487 Jose Santos Country Description 487 Overview of Regulatory Environment 488 Regulatory Requirements and Procedures 514 Annex I 516 Annex II 517 Future Trends 518 References 519 About the Author 519 RUSSIA 521 Alexander Rudakov Country Description 522 Regulatory Authorities in Russia 522 Requirements and Procedures 530 Future Trends 537 References 538 Chapter Appendices 540 SINGAPORE 549 Tan Shook Fong Country Description 549 Drug Regulation 551 Product Registration Procedures and Requirements 556 Other Licences and Certificates 563 Computerised Drug Registration System 565 Post-Marketing Surveillance 565 Other Related Controls 567 Future Trends 567 About the Author 568 Chapter Appendices 569 SLOVAK REPUBLIC 619 Ludevit Martinec Country Description 619 The Slovak Pharmaceutical Sector 621

10 Contents xi Regulatory Environment and Regulatory Authorities 622 Regulatory Requirements and Procedures 623 Regulatory Update 626 Registration Problems 631 Future Trends 632 Conclusion 633 About the Author 633 SOUTH AFRICA 635 Joy Eckard Country Description 635 Overview of Regulatory Environment and Background 637 Regulatory Authority 638 Regulatory Requirements and Procedures 639 References 665 About the Authors 667 Chapter Appendices 668 SWITZERLAND 677 Alan A. Chalmers Country Description Overview of Regulatory Environment 677 Regulatory Authorities 678 Regulatory Requirements and Procedures 679 Regulatory Procedures 679 Practical Aspects 687 Future Trends 688 Appendices > 689 References 689 About the Author 689 Chapter appendices 690 THAILAND 695 Pakdee Pothisiri and Yupin Lawanprasert Modern Pharmaceutical Products 696 Traditional and Herbal Pharmaceutical Products 696 Geographical and Health Administrative Background 697

11 xii International Pharmaceutical Registration Overview of Pharmaceutical Regulatory Background 700 National Regulatory Authorities 702 Technical Division 703 Regulatory Requirements and Procedures for Pharmaceutical Licensing and Registration 706 Future Trends of Pharmaceutical Registration in Thailand 714 References 715 About the Authors 716 Chapter Appendices 717 TUNISIA 733 Leila Kallel, Hassen Trabelsi, and Kamel Bouzouita Country Description 733 Overview of Regulatory Environment/Background 734 Regulatory Authorities 736 Regulatory Requirements and Procedures 740 Application for a Marketing Authorization (MA) 741 Registration Steps 744 References 752 Acknowledgments 753 About the Author 753 Chapter Appendices 754 TURKEY 773 Ilker Gelisen Regulatory Background and Environment 774 Ministry of Health (MOH) Address, Telephone and Fax Numbers 775 Requirements in Turkish Registration 775 Registration Process in Turkey 780 Future Trends 781 About the Author 783 UKRAINE 785 Aleksei V. Zhmuro, Yaroslav V. Dykun, and Andrey G. Solodarenko Abbreviations 785 Country Description 786 Overview of Regulatory Environment and Background 788

12 Contents xiii Regulatory Authorities 788 Regulatory Requirements and Procedures 789 Practical Aspects 793 Future Trends 795 References 795 About the Authors 796 Chapter Appendices 797 UNITED KINGDOM 803 Richard R. Vercoe Country Description 803 Overview of Regulatory Environment/Background 804 Regulatory Authorities 806 Regulatory Requirements and Procedures 812 Sources of Practical Regulatory Information 833 Acknowledgments 836 About the Author 836 UNITED STATES 837 MarkMathieu The FDA and The Food, Drug and Cosmetic Act 838 New Drug Development and Approval: The Principal Steps 839 The Investigational New Drug Application 841 The FDA's Review of the IND 842 Clinical Trials 843 The New Drug Application 844 The NDA Review Process 845 About the Author 847 INDEX 851