DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

More documents

Recommendations

Info

Drug Registration Guidance Document (<strong>DRGD</strong>)Granted Data Exclusivity/ Test Data Protection in the country of origin or in anycountry, recognized and deem appropriate by the Director of PharmaceuticalServices.b) Second indication of a registered drug product is made within twelve (12) monthsfrom the date the second indication is approved; ANDGranted Data Exclusivity/ Test Data Protection in the country of origin or in anycountry, recognized and deemed appropriate by the Director of PharmaceuticalServices.Before the Data Exclusivity is granted:a) The applicant of a new drug product containing a new chemical entity shallprovide to the Director of Pharmaceutical Services the undisclosed, unpublishedand non-public domain pharmaceutical test data, the origination, of whichinvolves a considerable effort; ORb) The applicant for a second indication of a registered drug product shall provide tothe Director of Pharmaceutical Services, the reports of new clinical investigationsother than bioavailability studies, conducted in relation to the second indicationand the origination of which has involved considerable effort.The Director of Pharmaceutical Services shall decide on whether the application willbe granted the Data Exclusivity. The period of the Data Exclusivity granted shall bemade on a case to case basis.The period of the Data Exclusivity shall not be more than:a) Five (5) years for a new drug product containing a new chemical entity; andb) Three (3) years for a second indication of a registered drug product. The periodof Data Exclusivity is for the data concerning the second indication only.Calculation of the period of Data Exclusivity:a) For a new drug product containing a new chemical entity, the period of DataExclusivity shall be calculated from the date the product is first registered orgranted marketing authorization AND granted Data Exclusivity/ Test DataProtection in the country of origin or in any country recognized and deemedappropriate by the Director of Pharmaceutical Services.b) For a second indication of a registered drug product, the period of DataExclusivity shall be calculated from the date the second indication is firstNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 52
Drug Registration Guidance Document (<strong>DRGD</strong>)approved AND granted Data Exclusivity/ Test Data Protection in the country oforigin or in any country recognized and deemed appropriate by the Director ofPharmaceutical Services.2.4 CONSIDERATION OF OTHER APPLICATIONS UPON THEGRANT OF DATA EXCLUSIVITYFor a registered new drug product containing a new chemical entity, registration ofany other drug product where the active moiety is in all respect the same as theactive moiety in the registered drug product which has been granted Data Exclusivityin Malaysia can be considered if:a) The applicant provides undisclosed, unpublished and non-public domainpharmaceutical test data, the origination of which involves a considerable effortto demonstrate the quality, safety and efficacy if the drug product submitted forregistration; ORb) The applicant has obtained consent in writing for right of reference or use of thetest data from a person authorised by the owner of the registered new drugproduct containing a new chemical entity.2.5 NON-APPLICATION OF DATA EXCLUSIVITYNothing in the Data Exclusivity shall:a) Apply to situations where compulsory licences have been issued or theimplementation of any other measures consistent with the need to protect publichealth and ensure access to medicines for all; orb) Prevent the Government from taking any necessary action to protect publichealth, national security, non-commercial public use, national emergency, publichealth crisis or other extremenly urgent circumstances declared by theGovernement.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 53
Page 1 and 2: Drug Registration Guidance Document
Page 11: Drug Registration Guidance Document
Page 102 and 103:
Drug Registration Guidance Document
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:
Appearance/organoleptic(odor, color
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:
ATTACHMENT 1Drug Registration Guida
Page 222 and 223:
Page 224 and 225:
Page 226 and 227:
Page 228 and 229:
PART IV: CLINICAL DOCUMENTSDrug Reg
Page 230 and 231:
ATTACHMENT 2Drug Registration Guida
Page 232 and 233:
Page 234 and 235:
Page 236 and 237:
APPENDIX 5:Drug Registration Guidan
Page 238 and 239:
1. GENERAL INFORMATIONSDrug Registr
Page 240 and 241:
Page 242 and 243:
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:
Page 270 and 271:
Page 272 and 273:
Page 274 and 275:
Route of AdministrationTAMC(CFU/g o
Page 276 and 277:
Page 278 and 279:
Page 280 and 281:
Page 282 and 283:
e) Example of label approved by the
Page 284 and 285:
Page 286 and 287:
Page 288 and 289:
Page 290 and 291:
Page 292 and 293:
Page 294 and 295:
Page 296 and 297:
Page 298 and 299:
Page 300 and 301:
Page 302 and 303:
Page 304 and 305:
Page 306 and 307:
Page 308 and 309:
Page 310 and 311:
Page 312 and 313:
Page 314 and 315:
Page 316 and 317:
Page 318 and 319:
Page 320 and 321:
Page 322 and 323:
Page 324 and 325:
Page 326 and 327:
Page 328 and 329:
Page 330 and 331:
Page 332 and 333:
Page 334 and 335:
Page 336 and 337:
Page 338 and 339:
Page 340 and 341:
Page 342 and 343:
Page 344 and 345:
Page 346 and 347:
Page 348 and 349:
Page 350 and 351:
Page 352 and 353:
Page 354 and 355:
Page 356 and 357:
Page 358 and 359:
Page 360 and 361:
Page 362 and 363:
Page 364 and 365:
Page 366 and 367:
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:
Page 496 and 497:
Page 498 and 499:
Page 500:
show all

DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Create successful ePaper yourself

Delete template?

Save as template?