DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

More documents

Recommendations

Info

Drug Registration Guidance Document (DRGD)5.5. The ICH M4Q Technical Guideline and ASEAN Common TechnicalRequirements (ACTR) provide details on the information to be included inthe API sections of an application dossier.5.6. Where the drug substance and the drug product are manufactured by thesame company, information on the production, quality control and stabilityof the drug substance may be submitted as part of the dossier for the drugproduct (ACTD) rather than in a separate DMF. However, the company isnot precluded from submitting a DMF for the drug substance if it prefers todo so.5.7 . The DMF is divided into two parts, namely the Open (or PRH‟s) part andthe Closed (or confidential) part.5.8 The documents required for an application making a reference to a DMFare as follows:From the PRH:o Open part of the DMF from the PRH, as part of the submittedproduct dossier (the open part contains most of the information inPart 2.S (ACTD) - i.e. sections S1, S2.1 and S3 to S7);• S1 General Information1.1 Nomenclature1.2 Structure1.3 General Properties• S2 Manufacture2.1 Manufacture(s)/Site of Manufacture• S3 Characterisation3.1 Elucidation of Structure and other Characteristics3.2 Impurities• S4 Control of API/Drug Substance4.1 Specification4.2 Analytical Procedures4.3 Validation of Analytical Procedures4.4 Batch Analysis4.5 Justification of Specification• S5 Reference Standards or Materials• S6 Container Closure System• S7 StabilityFrom the API Manufacturer:o The complete (open part and closed part) DMF from the APImanufacturer. The closed part contains the confidential informationin section Part 2.S.2. ACTD - i.e. section 2);National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 318
Drug Registration Guidance Document (DRGD)• S2 Manufacture2.1 Manufacture(s)/ Site of Manufacture2.2 Description of Manufacturing Process and ProcessControls2.3 Control of Materials2.4 Controls of Critical Steps and intermediates2.5 Process Validation and/or Evaluation2.6 Manufacturing Process Developmento An original Letter of Access (see below).The Letter of Access authorizes the NPCB to refer to the DMF, insupport of the application for a drug product. Thus, the Letter ofAccess must state the following:The name of the drug product (product name, dosage form andproduct strength) to be registered;The local PRH responsible for finished product registration; and,A declaration that both the local PRH and the NPCB shall benotified of any change in the API specification or in themanufacturing process that will likely affect the product‟s qualityor safety.It is the responsibility of the applicant to ensure that the completeDMF (i.e. both the applicant‟s Open part and the API manufacturer'sclosed part) is supplied to NPCB directly by the API manufacturerand that the applicant has access to the relevant information in theDMF concerning the current manufacture of the API.5.9. The API Manufacturer may submit the DMF via electronic copy (CD) orhardcopy (optional) directly to the NPCB to maintain confidentiality of thecontents. The information contained in the restricted part of the DMF willbe regarded as confidential and will only be evaluated in support of theapplications mentioned in the Letter of Access. The confidentialinformation will not be disclosed to any third party without a writtenauthorization from the API Manufacturer.5.10. Upon receipt of the DMF, a BPFK DMF number will be assigned to theapplication for product registration. For future correspondences, the PRHand the API Manufacture should make a reference to this assigned BPFKDMF number. Should there be deficiencies within the restricted part of theDMF; The NPCB will raise queries directly with the API Manufacturer. ThePRH referencing a DMF is required to include a copy of the APIManufacturer‟s Letter of Access in the application.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 319
Page 1 and 2:
Drug Registration Guidance Document
Page 3 and 4:
Page 5 and 6:
Page 7 and 8:
Page 9 and 10:
Page 11 and 12:
Page 13 and 14:
Page 15 and 16:
Page 17 and 18:
Page 19:
Page 22 and 23:
Page 24 and 25:
Page 26 and 27:
Page 28 and 29:
Page 30 and 31:
Page 32 and 33:
Page 34 and 35:
Page 36 and 37:
Page 38 and 39:
Page 40 and 41:
Page 42 and 43:
Page 44 and 45:
Page 46 and 47:
Page 48 and 49:
Page 50 and 51:
Page 52 and 53:
Page 54 and 55:
Page 56 and 57:
Page 58 and 59:
Page 60 and 61:
Page 62 and 63:
Page 64 and 65:
Page 66 and 67:
Page 68 and 69:
Page 70 and 71:
Page 72 and 73:
Page 74 and 75:
Page 76 and 77:
Page 78 and 79:
Page 80 and 81:
Page 82 and 83:
Page 84 and 85:
Page 86 and 87:
Page 88 and 89:
Page 90 and 91:
Page 92 and 93:
Page 94 and 95:
Page 96 and 97:
Page 98 and 99:
Page 100 and 101:
Page 102 and 103:
Page 104 and 105:
Page 106 and 107:
Page 108 and 109:
Page 110 and 111:
Page 112 and 113:
Page 114 and 115:
Page 116 and 117:
Page 118 and 119:
Page 120 and 121:
Page 122 and 123:
Page 124 and 125:
Page 126 and 127:
Page 128 and 129:
Page 130 and 131:
Page 132 and 133:
Page 134 and 135:
Page 136 and 137:
Page 138 and 139:
Page 140 and 141:
Page 142 and 143:
Page 144 and 145:
Page 146 and 147:
Page 148 and 149:
Page 150 and 151:
Page 152 and 153:
Page 154 and 155:
Page 156 and 157:
Page 158 and 159:
Page 160 and 161:
Page 162 and 163:
Page 164 and 165:
Page 166 and 167:
Page 168 and 169:
Page 170 and 171:
Page 172 and 173:
Page 174 and 175:
Page 176 and 177:
Page 178 and 179:
Page 180 and 181:
Page 182 and 183:
Page 184 and 185:
Page 186 and 187:
Page 188 and 189:
Page 190 and 191:
Page 192 and 193:
Page 194 and 195:
Page 196 and 197:
Page 198 and 199:
Page 200 and 201:
Page 202 and 203:
Page 204 and 205:
Page 206 and 207:
Page 208 and 209:
Page 210 and 211:
Page 212 and 213:
Page 214 and 215:
Page 216 and 217:
Page 218 and 219:
Page 220 and 221:
Page 222 and 223:
Page 224 and 225:
Page 226 and 227:
Page 228 and 229:
Page 230 and 231:
PART III: NON-CLINICAL DATADrug Reg
Page 232 and 233:
- All information must be provided
Page 234 and 235:
Page 236 and 237:
Page 238 and 239:
Page 240 and 241:
Page 242 and 243:
1.2 EXEMPTION FROM PRODUCT REGISTRA
Page 244 and 245:
Page 246 and 247:
Page 248 and 249:
Page 250 and 251:
Page 252 and 253:
Page 254 and 255:
Page 256 and 257:
Page 258 and 259:
Page 260 and 261:
Page 262 and 263:
Page 264 and 265:
Page 266 and 267:
Page 268 and 269: Drug Registration Guidance Document
Page 292 and 293: For product containing Red Yeast Ri
Page 368 and 369:
Page 370 and 371:
Page 372 and 373:
Page 374 and 375:
Page 376 and 377:
Page 378 and 379:
Page 380 and 381:
Page 382 and 383:
Page 384 and 385:
Page 386 and 387:
Page 388 and 389:
Page 390 and 391:
Page 392 and 393:
Page 394 and 395:
Page 396 and 397:
Page 398 and 399:
Page 400 and 401:
Page 402 and 403:
Page 404 and 405:
Page 406 and 407:
Page 408 and 409:
Page 410 and 411:
Page 412 and 413:
Page 414 and 415:
Page 416 and 417:
Page 418 and 419:
Page 420 and 421:
Page 422 and 423:
Page 424 and 425:
Page 426 and 427:
Page 428 and 429:
Page 430 and 431:
Page 432 and 433:
Page 434 and 435:
Page 436 and 437:
Page 438 and 439:
Page 440 and 441:
Page 442 and 443:
Page 444 and 445:
Page 446 and 447:
Page 448 and 449:
Page 450 and 451:
Page 452 and 453:
Page 454 and 455:
Page 456 and 457:
Page 458 and 459:
Page 460 and 461:
Page 462 and 463:
Page 464 and 465:
Page 466 and 467:
Page 468 and 469:
Page 470 and 471:
Page 472 and 473:
Page 474 and 475:
Page 476 and 477:
Page 478 and 479:
Page 480 and 481:
Page 482 and 483:
Page 484 and 485:
Page 486 and 487:
Page 488 and 489:
Page 490 and 491:
Page 492 and 493:
Page 494 and 495:
show all

DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Create successful ePaper yourself

Delete template?

Save as template?