International Pharmaceutical Registration

International Pharmaceutical Registration......Page 1
Introduction......Page 14
Editor Biography......Page 16
Contents......Page 3
Australia......Page 17
Contents......Page 0
COUNTRY DESCRIPTION......Page 18
The Present Legislative Controls......Page 20
Registration and Manufacture......Page 21
Clinical Trials......Page 22
Reimbursement......Page 23
Drugs and Poisons Scheduling......Page 24
Therapeutic Goods Administration (TGA)......Page 25
Health Access and Financing Division......Page 27
Australian Drug Evaluation Committee (ADEC)......Page 28
Category 1......Page 31
Category 3......Page 32
Listable Drug Products......Page 35
Switching from Prescription to Non-Prescription Status......Page 36
Applications for Reimbursement......Page 37
FUTURE TRENDS......Page 38
ABOUT THE AUTHOR......Page 39
GLOSSARY......Page 40
Belgium......Page 42
THE MEDICINES COMMISSION......Page 43
REGISTRATION PROCEDURE......Page 45
Transparency......Page 48
Over-the-Counter (OTC) Switching......Page 49
Food Supplements......Page 51
REFUSING, SUSPENDING OR REVOKING REGISTRATION......Page 53
Delay in Registration Time......Page 54
Reimbursement and Pricing......Page 57
Price......Page 58
REIMBURSEMENT......Page 59
Visa......Page 60
The Pharmacist Responsible for Pharmacovigilance......Page 61
INSPECTIONS......Page 62
A NEW MEDICINES INSTITUTE......Page 63
Public Health......Page 64
REFERENCES......Page 65
ABOUT THE AUTHOR......Page 66
OVERVIEW OF REGULATORY AFFAIRS......Page 67
ABOUT THE AUTHOR......Page 70
COUNTRY DESCRIPTION......Page 71
OVERVIEW OF REGULATORY ENVIRONMENT AND BACKGROUND......Page 73
The Dossier......Page 76
Assessment and Timing......Page 77
Postmarketing Surveillance......Page 80
ABOUT THE AUTHOR......Page 81
National Requirements for Registration of Medicinal Products Following EU Centralised Procedure*......Page 83
English Translation of Regulation No. 17 9 June 1995 (as amended)......Page 84
Annex No. 1 to para 2 of Article 2-Application Form......Page 86
Annex No. 2 to item @), subpara 1, para 2 of Article 2......Page 87
Annex No. 3 to subpara 2, para 2 of Article 2......Page 88
Annex No. 5 to subpara 4, para 2 of Article 2......Page 90
Annex No. 6 to Article 4......Page 92
Annex No. 8 to Article 6......Page 94
Annex No. 9 to para 1 of Article 7......Page 95
Canada......Page 96
FOOD AND DRUGS ACT......Page 97
PART C IN DRUG REGULATIONS-DIVISION 1......Page 98
ESTABLISHMENT LICENCES--DIVISION 1A......Page 99
GOOD MANUFACTURING PRACTICE (GMP)......Page 100
SCHEDULE C DRUGSDIVISION 3......Page 102
SCHEDULE D DRUGS-DIVISION 4......Page 104
NEW DRUGS--DIVISION 8......Page 105
New Drug Submission......Page 106
Abbreviated New Drug Submission......Page 107
Clinical Trials......Page 108
Experimental Studies......Page 109
NON-PRESCRIPTION DRUGSDIVISION 9......Page 110
PROPRIETARY MEDICINE-DIVISION 10......Page 111
ABOUT THE AUTHOR......Page 112
European Union......Page 113
THE DECENTRALISED PROCEDURE......Page 115
MUTUAL RECOGNITION PROCEDURE (MRP)......Page 116
MAKING THE MRP WORK......Page 117
CONCLUSION......Page 118
ABOUT THE AUTHOR......Page 119
COUNTRY DESCRIPTION......Page 120
Reforms......Page 122
Government Plans Announced June 1998......Page 123
Reforms of Health Safety......Page 124
Administrative Structures......Page 125
The Consultative Commissions......Page 127
The Networks......Page 128
REQUIREMENTS......Page 129
Requirements for Marketing-the Marketing Authorisation (MA)......Page 131
FUTURE TRENDS......Page 135
The French Agency for the Health Safety of Health Products......Page 136
Mission-Evaluation and Control of the Market......Page 137
French Agency of Health Safety of Foods......Page 138
French Blood Establishment......Page 139
ABBREVIATIONS......Page 140
REFERENCES......Page 141
ABOUT THE AUTHOR......Page 142
Germany......Page 143
OVERVIEW OF REGULATORY ENVIRONMENT AND BACKGROUND......Page 144
REGULATORY AUTHORITIES......Page 145
REGULATORY REQUIREMENTS AND PROCEDURES......Page 146
Registration of Homoeopathic Drugs......Page 151
FUTURE TRENDS......Page 153
ABOUT THE AUTHOR......Page 154
Population......Page 155
Potential......Page 156
Priorities......Page 157
Market Development......Page 158
Registration o f the Pharmaceutical Company......Page 159
Documentary Requirements......Page 162
Ministry of Health......Page 165
Free Sales Certificate......Page 166
Freely Sold in the Country of Origin......Page 167
Good Manufacturing Practice (GMP) Certificate......Page 168
Price Certificate......Page 169
Registration Status......Page 170
Samples......Page 171
Packaging Elements......Page 172
Analytical Certificates......Page 174
Stability......Page 176
Ministry of Health Quality Control Laboratory......Page 177
REFERENCES......Page 178
ABOUT THE AUTHOR......Page 179
Hungary......Page 180
COUNTRY DESCRIPTION......Page 181
OVERVIEW OF REGULATORY ENVIRONMENT UNTIL LATE 1990s......Page 182
OVERVIEW OF THE RECENT REGULATORY ENVIRONMENT......Page 186
REGULATORY AUTHORITIES......Page 189
REGULATORY REQUIREMENTS AND PROCEDURES......Page 190
FUTURE TRENDS......Page 197
REFERENCES......Page 198
ABOUT THE AUTHOR......Page 200
REGULATORY LAWS......Page 201
SCHEDULES......Page 202
REGISTRATION OF NEW DRUGS......Page 203
Clinical Trial Requirements......Page 204
Contents of the Registration Dossier......Page 205
Marketing Information......Page 206
REGULATORY ENVIRONMENT AND PRACTICES......Page 207
Guidelines for Bioavailability/Bioequivalence Studies......Page 208
ADVERTISEMENT OF DRUGS......Page 209
OTHER LAWS......Page 210
ABOUT THE AUTHORS......Page 211
ABBREVIATIONS AND NOMENCLATURE......Page 212
THE PHARMACEUTICAL INDUSTRY IN IRELAND......Page 213
STRUCTURE AND FUNCTION OF THE BOARD......Page 214
CLINICAL TRIALS......Page 216
ASSESSMENT AND AUTHORISATION PROCESS......Page 217
REJECTION PROCEDURE......Page 219
Full Dossier-Complex......Page 220
Service Items......Page 221
Competition......Page 222
Harmonization......Page 223
ABOUT THE AUTHOR......Page 224
CHAPTER APPENDIX......Page 225
The Authorities......Page 226
Administrative Requirements for Registration......Page 227
Area......Page 228
Health......Page 229
Pharmaceuticals Market......Page 230
Pharmaceutical Registration......Page 231
Patent Protection......Page 232
The Pharmaceutical Administration......Page 233
Institute for the Standardization and Control o f Pharmaceuticals......Page 234
Registration Holder......Page 235
Batch Control......Page 236
International Relationships......Page 237
Expert Advisory Registration Committee......Page 238
The Applicant......Page 239
Declarations......Page 240
Basic Information Sheet......Page 241
Classification of Products and Requirements......Page 242
Chemical and Pharmaceutical Documentation-File A......Page 243
Stability Data......Page 244
Products Manufactured Under Know-How Arrangements......Page 245
Definition......Page 246
The Standard......Page 247
Outer Package......Page 248
CLINICAL RESEARCH......Page 249
Other Elements......Page 250
Homeopathy......Page 251
Medical Devices......Page 252
ABOUT THE AUTHOR......Page 253
PUBLIC HEALTH ORDINANCE FOOD) (NEW VERSION), 1983......Page 254
Application Form for Pharmaceutical Product Registration in the Drug Registry......Page 255
Quality Certificate Application......Page 257
Plant Master File "Pharmaceuticals"......Page 258
Basic Information Sheet on the Pharmaceutical Product......Page 259
Application Form for Renewal of Registration of a Pharmaceutical Product in the Drug Registry......Page 261
Consumer's Leaflet (Appendix 8)......Page 262
Required Data on Manufacturing Method and Quality Control......Page 266
Public Health Regulations (Food) (Food Supplements), 1997......Page 267
Japan......Page 268
COUNTRY DESCRIPTION......Page 269
OVERVIEW OF REGULATORY ENVIRONMENT/BACKGROUND......Page 270
Approval and Licensing Procedures......Page 272
Flowchart of Drug Manufacturing/Import Approval and Licensing Procedure......Page 273
Direct Approval Application by Drug Manufacturers in Foreign Countries......Page 275
REGULATORY AUTHORITY......Page 276
Application for Approval to Manufacture/Import a Drug......Page 277
Required Data......Page 281
Addition or Changes o f the Importer o r the Country o f Origin......Page 284
Bioequivalence Data......Page 285
General Guidance......Page 286
Data on Physicochemical Properties, Standards and Test Methods (Data: 6. 1 3 in Table 3)......Page 287
Standards and Test Methods (Data: b-3 in Table 3)......Page 288
Data on Stability (Data: c. 1-3 in Table 3)......Page 290
Stability Testing......Page 291
Data on Toxicity......Page 292
Guidelines on Toxicity Studies......Page 293
Repeated Dose Toxicity......Page 294
Reproductive and Developmental Toxicity......Page 296
Skin Sensitization Tests......Page 297
Skin Photosensitization Test......Page 298
Mutagenicity Study......Page 299
Carcinogenicity Study......Page 300
GLP......Page 301
Data on Pharmacological Action......Page 302
Data on Absorption. Distribution, Metabolism and Excretion/ADME......Page 303
Clinical Trial Data......Page 306
Codevelopment......Page 312
Drug Additives......Page 313
Drug License Approval......Page 314
Repackaging and Contracted Manufacturing......Page 316
Transfer of Approval......Page 318
FUTURE TRENDS......Page 319
ABOUT THE AUTHOR......Page 320
Handling o f the Required Data......Page 321
Handling of Corn bination Drugs......Page 323
Required Data in Codevelopment......Page 324
Method of Preparing the Data......Page 326
Other......Page 327
Geographical Location......Page 328
General......Page 329
REGULATORY REQUIREMENTS AND PROCEDURES......Page 330
Documentation and Other Requirements......Page 331
REGISTRATION PROCEDURES......Page 333
Generics......Page 334
Revalidation Procedures......Page 335
PRACTICAL ASPECTS......Page 336
ACKNOWLEDGMENT......Page 337
ABOUT THE AUTHOR......Page 338
Country Profile......Page 339
Health System in Malaysia......Page 340
The Relevant Acts......Page 341
Registration of Pharmaceutical Products......Page 342
The NPCB......Page 344
Correspondence Addresses......Page 345
Stage 1......Page 346
Stage 2......Page 347
Abridged Evaluation......Page 348
Registration of Traditional Medicines......Page 350
Renewal of Registration......Page 351
Processing Time for Registration......Page 352
CFS......Page 353
Transparency of Processes......Page 354
ABOUT THE AUTHOR......Page 355
COUNTRY DESCRIPTION......Page 356
Medicines That Have to Be Registered......Page 357
Classification of Medicines......Page 358
Impact of Registration on the Volume of Medicines......Page 359
MEB and the Pharmaceutical Industry......Page 360
Code o f Conduct for Research with Registration Files......Page 362
REGULATORY AUTHORITIES......Page 363
The Research Committee......Page 366
Procedures......Page 367
Variations in Registrations......Page 368
Evaluation Criteria......Page 369
Chemical-Pharmaceutical Mutual Recognition......Page 373
Homeopathic Medicines......Page 374
Summary of Product Characteristics......Page 375
Patient Information Leaflet......Page 376
Procedures for Reporting ADRs......Page 377
Procedure for the Reporting o f ADRs o f Approved Active Substances by Registration Holders......Page 378
Procedure for the Reporting o f ADRs of Nonregistered Medicines by Registration Holders......Page 379
Recall Procedure and the Orange Hand Envelope......Page 380
FUTURE TRENDS......Page 382
ABOUT THE AUTHOR......Page 383
New Zealand......Page 385
Politics and Government......Page 386
Overview of the Regulatory Environment for Therapeutic Products......Page 387
Medicines......Page 388
Related Products......Page 389
Medical Devices......Page 390
Cosmetics......Page 391
Dietary Supplements......Page 392
Consent to Distribute New and Changed Medicines......Page 393
Consent to Distribute New and Changed Related Products......Page 395
Evaluation Team......Page 396
Compliance Team......Page 397
Business Development and Support Team......Page 398
Medicines Assessment Advisory Committee......Page 399
Pharmaceutical Management Agency Limited......Page 400
New Medicines and Related Products......Page 402
Changed Medicines and Related Products......Page 405
Data Requirements......Page 406
Assessment Procedures......Page 407
Timelines......Page 408
Bioequivalence and Interchangeability of Multi-source Medicines......Page 409
Medicine Data Sheets......Page 410
Clinical Trials......Page 411
Licences to Manufacture, Pack, Wholesale and Sell Medicines......Page 412
ADR Monitoring......Page 413
Trans-Tasman Mutual Recognition......Page 414
Healthcare and Therapeutic Products Bill......Page 415
ABOUT THE AUTHOR......Page 416
Principal New Zealand Regulatory Guidelines and Reference Documents......Page 417
Data Requirements for Applications for Consent to Distribute New Medicines and New Related Products......Page 418
Medsafe Fees for Regulatory Activities......Page 419
Medsafe Performance Targets for the Evaluation of Applications......Page 420
Principal New Zealand Pharmaceutical Publications......Page 421
New Zealand Regulatory and Funding Agencies and Pharmaceutical Manufac- turers Associations......Page 422
Nigeria......Page 424
Land and Resources......Page 426
Education and Culture......Page 427
Health and Medical Issues......Page 428
Government......Page 429
OVERVIEW OR REGULATORY ENVIRONMENT/BACKGROUND......Page 430
NAFDAC Council......Page 433
Functions and Powers o f the Agency......Page 434
Other Powers-to Enter Premises, etc.......Page 435
Pharmacists Council of Nigeria (PCN)......Page 436
REGULATORY REQUIREMENTS AND PROCEDURES......Page 437
Applications/Manufacturer......Page 438
Labelling......Page 439
Imported Drug Products......Page 440
Product Reghtration Process......Page 441
Locally Manufactured Drug Products......Page 442
Format of Dossier for Product......Page 443
FUTURE TRENDS......Page 447
Drug Quality Surveillance......Page 449
General......Page 451
REFERENCES......Page 452
ABOUT THE AUTHOR......Page 454
Poland......Page 455
Polish History......Page 456
Current Figures, the Healthcare System, the Pharmaceutical Market......Page 457
Drug Reimbursement System......Page 461
Advertising......Page 462
BACKGROUND OF REGULATORY ENVIRONMENT......Page 463
FEES......Page 466
Department of Pharmacy of the MOHSW......Page 468
BUREAU OF DRUG AND MEDICAL DEVICES REGISTRATION......Page 470
Drug Institute......Page 471
The Basis for Drug Registration......Page 472
Requirements on Documentation for Drug Registration......Page 473
The Patient Information Leaflet......Page 477
Registration Procedure......Page 479
Registration of Herbal Medicines......Page 480
Registration Certificate......Page 482
Renewals o f Registration......Page 483
FUTURE TRENDS......Page 485
ABOUT THE AUTHOR......Page 487
COUNTRY DESCRIPTION......Page 488
Ministry of Health......Page 489
Languages Accepted in the File......Page 515
Delivery of the MA Request......Page 516
Part II-Chemical and Pharmaceutical Documentation......Page 517
Summary of Characteristics of the Drug......Page 518
FUTURE TRENDS......Page 519
ABOUT THE AUTHOR......Page 520
Russia......Page 521
REGULATORY AUTHORITIES IN RUSSIA......Page 522
The SCD for Control of Pharmaceuticals and Medical Equipment......Page 523
The Bureau of Registration for Pharmaceuticals, Medical Equipment and Devices......Page 524
The State Pharmacological Committee......Page 525
The State Institute of Preclinical and Clinical Drug Evaluation......Page 526
The State Research Institute o f Drug Standards and Control......Page 528
Other Bodies Participating in Product Review and Registration......Page 529
Drug Registration Procedure......Page 530
Clinical Trials......Page 532
Bioequivalence Studies......Page 533
OTC Products......Page 534
Product Registration Renewal......Page 535
International Cooperation......Page 536
FUTURE TRENDS......Page 537
REFERENCES......Page 538
Letter of Intent1......Page 540
Application for Registration/Reregistration of the Pharmaceutical in the Rus- sian Federation......Page 541
List of Documents for the Registration of New Pharmaceuticals in the Russian Federation......Page 542
List of Documentation for Registration of Generic and Licensed Pharmaceuti- cals in the Russian Federation......Page 543
List of Documents Required for the Bureau of Registration for Registration1 Reregistration of Pharmaceuticals......Page 544
List of Documents Required for Permission on Clinical Trials......Page 545
List of Documents Required for Registration Medicine as a Nonprescription Drug......Page 546
List of Documents Required for the Reclassification Drugs from Prescription to OTC Status......Page 547
List of Documentation Required for Reg;istration/Reregistration of the Substance in the Russian Federation......Page 548
Population......Page 549
Health Services......Page 550
History of Drug Registration in Singapore......Page 551
The Medicines Advisory Committee......Page 553
Exemption from Drug Registration......Page 554
Prescription-Only Medicines......Page 555
Particulars o f Manufacturer......Page 556
Particulars of Product......Page 557
Rejection o f Products From Registration......Page 560
Major Amendment......Page 561
Minor Amendments......Page 562
Wholesale Dealer's Licences (Appendix 5)......Page 563
Special Permit for Import of Unregistered Medicinal Products (Appendix 9)......Page 564
Quality Surveillance Programme......Page 565
Assessment of Recall......Page 566
FUTURE TRENDS......Page 567
APPENDICES......Page 568
APPLICATION FOR A PRODUCT LICENCE......Page 569
LIST OF ENCLOSURES......Page 576
Information to Be Included in the Summary of Clinical Paper......Page 577
GUIDE TO AMENDMENT OF PRODUCT LICENCE......Page 578
DRA-1 INCLUSION OF NEW INDICATION OR NEW DOSAGE REGIME......Page 585
DRA-2 CHANGE OF PRODUCT LICENCE HOLDER......Page 587
NOTES ON APPLICATION FOR A LICENCE TO IMPORT MEDICINAL PRODUCTS......Page 591
APPLICATION FOR A LICENCE TO IMPORT MEDICINAL PRODUCTS......Page 592
LIST OF ENCLOSURES......Page 594
Additional Notes to Applicant of Import Licence on Consignment Basis......Page 595
APPLICATION FOR A LICENCE TO SELL MEDICINAL PRODUCTS BY WAY OF WHOLESALE DEALING......Page 596
APPLICATION FOR A LICENCE TO SELL MEDICINAL PRODUCTS BY WAY OF WHOLESALE DEALING......Page 597
LIST OF ENCLOSURES......Page 600
List of Documents Required to be Submitted When Applying for an Import Licence or Wholesale Dealer's Licence for Medicinal Products......Page 601
NOTES ON APPLICATION FOR A LICENCE TO MANUFACTURE/ASSEMBLE MEDICINAL PRODUCTS......Page 602
APPLICATION FOR A LICENCE TO SELL MANUFACTURE/ ASSEMBLE MEDICINAL PRODUCTS......Page 603
LIST OF ENCLOSURES......Page 608
NOTES ON APPLICATION FOR A CERTIFICATE FOR EXPORTER OF MEDICINAL PRODUCTS......Page 609
APPLICATION FOR A CERTIFICATE FOR EXPORTER OF MEDICINAL PRODUCTS......Page 610
LIST OF ENCLOSURES......Page 612
THE SCHEDULE......Page 613
APPLICATION FOR APPROVAL TO IMPORT MEDICINAL PRODUCTS SOLELY FOR THE PURPOSE OF RE-EXPORT......Page 614
APPLICATION FOR APPROVAL TO IMPORT AN UNREGISTERED MEDICINAL PRODUCT......Page 616
APPLICATION FORM FOR APPROVAL TO IMPORT AN UNREGISTERED MEDICINAL PRODUCT......Page 617
COUNTRY DESCRIPTION......Page 619
THE SLOVAK PHARMACEUTICAL SECTOR......Page 621
REGULATORY ENVIRONMENT AND REGULATORY AUTHORITIES......Page 622
REGULATORY REQUIREMENTS AND PROCEDURES......Page 623
Mutual Recognition Procedure......Page 625
New Drug Regulations......Page 626
Labelling, Leaflet and Summary of the Product Characterisations......Page 627
Supervision......Page 628
Renewal Applications......Page 629
Legal Prerequisites for the Conduct of Clinical Trials......Page 630
REGISTRATION PROBLEMS......Page 631
Draft for the Amendment of the Medicines Act......Page 632
ABOUT THE AUTHOR......Page 633
COUNTRY DESCRIPTION......Page 634
Health......Page 635
OVERVIEW OF REGULATORY ENVIRONMENT AND BACKGROUND......Page 636
REGULATORY AUTHORITY......Page 637
The Legal Position......Page 638
Medicines Subject to Registration......Page 640
Some Definitions......Page 641
The Registration Process......Page 643
Samples......Page 645
Amendments to the Registration Application......Page 646
The Registration Number......Page 647
Hints on Completing the Registration Application Form......Page 649
Annexure I (Package Insert and Labelling)......Page 650
Annexure 2 (Formulation)......Page 652
Annexure 3 (Chemical Details of the Actives)......Page 653
Annexures 4,5, 6 (Raw Material Specifications, Analytical Procedures and Control)......Page 654
Annexure 7A and Annex 7B......Page 656
Annexure 8A (Container Specifications)......Page 657
Annexure 9A (Final Product Control)......Page 658
Annexure 10 (Stability Data)......Page 659
Annexure 10(b)......Page 660
Annexure 11......Page 661
Annexure 13 (Pharmaceutical and Biological Availability)......Page 662
Annexure 16 (Pharmaceutical Development)......Page 663
REFERENCES......Page 664
ABOUT THE AUTHORS......Page 666
Product Pre-Registration/Evaluation Report......Page 667
Pharmaceutical Evaluation Document......Page 672
COUNTRY DESCRIPTION......Page 675
OVERVIEW OF REGULATORY ENVIRONMENT......Page 676
Regulatory Basis......Page 677
Documentation......Page 678
REGULATORY PROCEDURES......Page 682
PRACTICAL ASPECTS......Page 685
FUTURE TRENDS......Page 686
ACKNOWLEDGMENT......Page 687
Organisation chart of IKS.......Page 688
Comparison of Professional Product Information in Switzerland......Page 689
IKS Application Form for Registration......Page 690
IKS Application Form for Registration......Page 691
Thailand......Page 692
TRADITIONAL AND HERBAL PHARMACEUTICAL PRODUCTS......Page 693
Health Administrative Background......Page 694
Government Sector......Page 695
Non-Governmental Organizations......Page 696
Laws and Regulations......Page 697
Organizational Infrastructure of Pharmaceutical Control System......Page 698
Inspection Division......Page 699
Roles and Responsibilities on Pharmaceutical Administration System......Page 700
Quality Control Laboratories......Page 702
REGULATORY REQUIREMENTS AND PROCEDURES FOR PHARMACEUTICAL LICENSING AND REGISTRATION......Page 703
Pharmaceutical Licensing......Page 704
Modern Pharmaceutical Product Registration......Page 705
New Pharmaceutical Product Registration......Page 706
Clinical Trials Approval......Page 708
Status of Reimbursement and Price Controls for Pharmaceutical Products......Page 709
Therapeutic Priorities-Potential for Fast Tract Registrations......Page 710
Harmonization of Regulations With Other Countries......Page 711
REFERENCES......Page 712
ABOUT THE AUTHORS......Page 713
CHAPTER APPENDIX 1......Page 714
COUNTRY DESCRIPTION......Page 729
Pharmaceutical and Medicinal Products Sector......Page 730
Medicinal Product Registration......Page 731
Direction of Pharmacy and Medicinal Products......Page 732
Tunisian Central Pharmacy (PCT) and the Control on Import......Page 733
National Laboratory of Drugs Control......Page 734
Pasteur Institute......Page 735
REGULATORY REQUIREMENTS AND PROCEDURES......Page 736
Components of an MA File......Page 737
REGISTRATION STEPS......Page 740
Application for a Renewal of an MA......Page 745
Suspension/Withdrawal of an MA......Page 746
Exceptional and Temporary Authorization......Page 747
REFERENCES......Page 748
ABOUT THE AUTHORS......Page 749
General Data on Tunisia......Page 750
Summary of registration procedure.......Page 753
ORDERS......Page 754
English Translation of the National Drug Laws......Page 756
Addresses of Important Public Health Institutions......Page 767
Turkey......Page 768
REGULATORY BACKGROUND AND ENVIRONMENT......Page 769
Administrative Information......Page 770
Composition......Page 771
Finished Product Control Tests......Page 772
Clinical Aduisory Committee......Page 773
Pricing......Page 774
Request for Samples for Analysis......Page 775
FUTURE TRENDS......Page 776
ABOUT THE AUTHOR......Page 778
ABBREVIATIONS......Page 779
COUNTRY DESCRIPTION......Page 780
REGULATORY AUTHORITIES......Page 782
REGULATORY REQUIREMENTS AND PROCEDURES......Page 783
PRACTICAL ASPECTS......Page 787
Procedures for Importation of Drugs......Page 788
REFERENCES......Page 789
ABOUT THE AUTHORS......Page 790
English Translation of Important Chapters of the Local Drug Law......Page 791
English Translation of Important Chapters of the Local Drug Law......Page 795
Population and Demography......Page 796
OVERVIEW OF REGULATORY ENVIRONMENT/BACKGROUND......Page 797
Scope of Licensing Control......Page 798
Advisory Committees......Page 799
Advisory Committee on Borderline Substances......Page 803
Medical Devices Agency......Page 804
Clinical Trials......Page 805
Clinical Trial Exemption (ClX) Scheme......Page 806
Clinical Trial Certificate......Page 809
Doctor Dentist Exemption @Dm Scheme......Page 810
MAS and Variations......Page 811
Appeals Procedures......Page 813
Licensing Fees......Page 814
Patient Information Leaflets (PILs) and Labels......Page 816
Sel fRegulation......Page 817
Advertising to Health Professionals......Page 818
Medicines Control Agency......Page 820
Legal Status and Re-Classification......Page 821
Homoeopathic Medicinal Products Registration Scheme......Page 823
Borderline Between Medicinal Product, Cosmetic, Medical Device and Health Food......Page 824
MAIL......Page 826
Annual Reports......Page 827
British National Formulary......Page 828
ABOUT THE AUTHOR......Page 829
United States of America......Page 830
THE FDA AND THE FOOD, DRUG AND COSMETIC ACT......Page 831
NEW DRUG DEVELOPMENT AND APPROVAL: THE PRINCIPAL STEPS......Page 832
THE INVESTIGATIONAL NEW DRUG APPLICATION......Page 834
THE FDA's REVIEW OF THE IND......Page 835
CLINICAL TRIALS......Page 836
THE NEW DRUG APPLICATION......Page 837
THE NDA REVIEW PROCESS......Page 838
ABOUT THE AUTHOR......Page 840