DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

More documents

Recommendations

Info

Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIED6. Replacement of anexcipient with acomparable excipientand/or change in contentof excipient.A2.1B1.2P1P4.1P4.2P3.2P3.2.1E11P5.4P8E12D1D2D3(if applicable)A4.2B1.2B2.1B2.2B3B4B5F10F12D1D2D3(if applicable)CONDITIONS1. Finished product release and end of shelf lifespecification remains the same.2. There is no change in dissolution profile for oralsolid dosage forms (where applicable).3. Replacement of an excipient with a comparableexcipient of the same functional characteristics.4. No changes on the specification of the excipientfor product specific requirements (e.g. particle sizeprofiles, polymorphic form, etc.), if applicable.5. Any new excipient does not include the use ofmaterials of human or animal origin for whichassessment is required of viral safety data.SUPPORTING DOCUMENTS1. Comparison of new and existing formula.2. Batch Manufacturing Formula.3. Excipient specification (if applicable).4. Manufacturing process with amendments.5. Certificate of Analysis (CoA) of drug product.6. Justification for not submitting a newbioequivalence study according to ASEANGuidelines for the Conduct of Bioavailability andBioequivalence Studies (where applicable).7. Comparative dissolution profile data of at leastone representative pilot/production batch of thedrug product between the currently approved andNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 460
Drug Registration Guidance Document (DRGD)NO.VARIATION TYPE II(MAJOR VARIATION)FULLEVALUATIONAFFECTED FIELDSABRIDGEDEVALUATIONSUPPORTING DOCUMENTS REQUIRED ANDCONDITIONS APPLIEDproposed solid dosage forms formulation (whereapplicable).8. Stability data of drug product (please refer toASEAN Guideline On Stability Study of DrugProduct)9. Revised drafts of the package insert and labelingincorporating the proposed variation (whereapplicable).10. Batch analysis data.11. Product interchangeability/ equivalent evidence (ifany).12. Justification for the change supported byappropriate development of pharmaceutics.13. New unit formula for coating agent (whereapplicable).7. Change in batch size B1.2E11P5.4P3.4E12P3.2P3.2.1(if applicable)B1.2F10F12B2.1B2.2(if applicable)CONDITIONS1. The change does not affect the reproducibilityand/or consistency of the product.2. No change to the manufacturing method nor to thein-process controls other that those necessitatedby the change in batch-size, e.g. use of differentsize equipment.3. Finished product release and end of shelf lifespecification remains the same.SUPPORTING DOCUMENTS1. Comparative tabulated format of the proposed andNational Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 461
Page 2 and 3:
Drug Registration Guidance Document
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 and 20:
Page 21 and 22:
Page 23 and 24:
Page 25 and 26:
Page 27 and 28:
Page 29 and 30:
Page 31:
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:
Appearance/organoleptic(odor, color
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:
ATTACHMENT 1Drug Registration Guida
Page 216 and 217:
Page 218 and 219:
Page 220 and 221:
Page 222 and 223:
PART IV: CLINICAL DOCUMENTSDrug Reg
Page 224 and 225:
ATTACHMENT 2Drug Registration Guida
Page 226 and 227:
Page 228 and 229:
Page 230 and 231:
APPENDIX 5:Drug Registration Guidan
Page 232 and 233:
1. GENERAL INFORMATIONSDrug Registr
Page 234 and 235:
Page 236 and 237:
Page 238 and 239:
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:
Route of AdministrationTAMC(CFU/g o
Page 270 and 271:
Page 272 and 273:
Page 274 and 275:
Page 276 and 277:
d) Example of label approved by the
Page 278 and 279:
Page 280 and 281:
Page 282 and 283:
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: Drug Registration Guidance Document
Page 486: Drug Registration Guidance Document
show all

DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Create successful ePaper yourself

Delete template?

Save as template?