Designation of Pharmaceuticals Required Securing
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Designation of Pharmaceuticals Required securing Pharmaceutical Equivalence Ministry of Food & Drug Safety Notification No. 2014- 189 (Nov. 26, 2014, Amended) Article 1 (Purpose) In accordance with Article 31(2) and 42(1) of the 「Pharmaceutical Affairs Act」, Articles 4(1)(3) of the 「Regulation on Safety of Medicinal Products, etc.」 and Article 57 of the 「Narcotics Control Act.」, the purpose of this Notification is to set forth the appropriate standards for Pharmaceuticals approval by providing for designates pharmaceuticals required to submit bioequivalence study results and comparative clinical study results, and also designates pharmaceuticals required to submit test results of not using biological matters such as comparative dissolution test in the approval of pharmaceutical manufacturing/marketing and import. Article 2 (Designation of pharmaceuticals requiring pharmaceuticals equivalence test) ① In accordance with Article 4(1)(3)(b) of the 「Regulation on Safety of Medicinal Products, etc..」, Tablets, capsules, or suppository of which ingredients are the same as previously approved pharmaceuticals for manufacturing/marketing and import, are one of the following subparagraph. 1. Conventional pharmaceuticals, their salts and derivatives comprised of a single active pharmaceutical ingredient as listed in the attached Table 1, which are determined by the claim quantity of medical expense of health insurance submitted to the President of Health Insurance Review and Assessment Service by the healthcare institutions as described in Article 43 of the 「National Health Insurance Act」. 2. Expensive pharmaceuticals, their salts and derivatives comprise of a single active pharmaceutical ingredient as listed in the attached Table 2, which are determined by the invoiced amounts of medical expense of health insurance divided by the claim quantity submitted to the President of Health Insurance Review and Assessment Service by the healthcare institutions as described in Article 43 of the 「National Health Insurance Act」. 3. Other pharmaceuticals required securing pharmaceutical equivalence, their salts and isomers comprise of a single active pharmaceutical ingredient as listed in the attached Table 3. 4. Fixed-dose combination of pharmaceuticals containing ingredients, their salts and isomers as listed in the attached Table 1, 2, and 3. ② In accordance with the partial clues with Article 4(1)(3) of the 「Regulation on Safety of Medicinal Products, etc.」, Pharmaceuticals needed to submit test results of comparative dissolution test, etc., in which biological matters are not used, are one of the following subparagraphs. 1. Pharmaceuticals, their salts and their derivatives comprised of single ingredients listed in the attached Table 4. 2. Fixed-dose combination of pharmaceuticals comprising of ingredients listed in the attached Table 4, their salts and derivatives. Article 3 (Review Period) According to Article 8 of the 「Framework Act on Administrative Regulations」 and the 「Regulation on Issuance and Management of Instructions and Rules」 (Presidential Instruction No. 248), validity of regulations must be reviewed and other relevant actions accompanied by every 3 years (by December 31 of every third year) starting January 1, 2014. ADDENDA <No. 2014-189, Nov. 26, 2014> Article 1 (Enforcement Date) This Notification is to be effective from the date of notification. Provided, That pharmaceutical approval or notification application on ingredients falling into No. 49 to 64 of Appendix 3 shall be effective from January 1, 2016. Article 2 (Example of Application) This Notification submitted to Minister of Food and Drug Safety or Commissioner of Regional office of Food and Drug Safety after the enforcement date of this notification applies to application (including amendment) for approval or notification (including amendment) of pharmaceutical manufacturing·marketing and import. Provided, that this notification can be applied in the case that a pharmaceutical is approved or notified for manufacturing·marketing and import even before the enforcement date of this notification. [Attached Table 1] Conventional Pharmaceuticals Serial number Ingredient 1 acarbose 2 acebrophylline 3 aceclofenac 4 acemetacin 5 acepifyline 6 acetylcarnitine HCl 7 aclatonium napdisilate 8 acyclovir 9 afloqualone 10 alibendol 11 allopurinol 12 alprazolam 13 <deletion> 14 <deletion> 15 <deletion> 16 <deletion> 17 <deletion> 18 amoxicillin 19 atenolol 20 atorvastatin(calcium) 21 azelastine HCl 22 bacampicillin HCl 23 baclofen 24 barnidipine HCl 25 benexate betadex 26 benidipine HCl 27 <deletion> 28 benztropine mesylate 29 bepotastine besilate 30 beraprost sodium 31 betaxolol HCl 32 bethanechol chloride 33 biphenyl dimethyl dicarboxylate 34 bisoprolol hemifumarate 35 bromazepam 36 buspirone HCl 37 calcitriol 38 <deletion> 39 candesartan cilexetil 40 captopril 41 carbamazepine 42 caroverine HCl 43 carvedilol 44 cefaclor 45 cefadroxil 46 cefatrizine propylene glycol 47 cefdinir 48 cefditoren pivoxil 49 cefixime 50 celecoxib 51 cephradine 52 cetraxate HCl 53 chlordiazepoxide HCl 54 chlorphenesin carbamate 55 <deletion> 56 ciclacillin 57 cilazapril 58 cilnidipine 59 cilostazol 60 cimetidine 61 cimetropium bromide 62 ciprofloxacin HCl 63 clarithromycin 64 clonazepam 65 cloperastine HCl 66 clopidogrel 67 clotiazepam 68 codeine phosphate 69 colchicine 70 collinalpocereate 71 <deletion> 72 dextromethorphan Hbr 73 diacerhein 74 diazepam 75 diclofenac sodium 76 diethylamine ethyl theophylline 77 difemerine HCl 78 digoxin 79 <deletion> 80 diphenylhydantoin sodium 81 dipyridamole 82 divalproex sodium 83 dobesilate calcium 84 domperidone 85 domperidone maleate 86 doxazocin mesylate 87 <deletion> 88 doxofylline 89 doxycycline 90 ebastine 91 emedastine fumarate 92 enalapril maleate 93 eperisone HCl 94 eprosartan mesylate 95 erdosteine 96 erythromycin estolate 97 erythromycin(enteric coated 215mg) 98 estrogens(conjugated) 99 etizolam 100 etodolac 101 famotidine 102 felodipine 103 fenofibrate 104 fenoprofen calcium 105 fenoterol Hbr 106 fexofenadine 107 finasteride 108 flavoxate HCl 109 fluconazole 110 flunarizine HCl 111 flunitrazepam 112 fluoxetine HCl 113 formoterol fumarate 114 fosinopril sodium 115 furosemide 116 gabapentin 117 <deletion> 118 gliclazide 119 glimepiride 120 haloperidol 121 hexoprenaline sulfate 122 hydrochlorothiazide 123 <deletion> 124 hydroxychloroquine sulfate 125 hydroxyzine HCl 126 ibudilast 127 imidapril HCl 128 imipramine HCl 129 indapamide 130 irbesartan 131 isoniazid 132 <deletion> 133 isosorbide mononitrate 134 itopride 135 itraconazole 136 <deletion> 137 ketotifen fumarate 138 lacidipine 139 lamivudine 140 lamotrigin 141 lecithin iodide 142 lercanidipine HCl 143 levofloxacin 144 levosulpiride 145 levothyroxine sodium 146 limaprost alpha-cyclodextrin 147 lisinopril 148 lithium carbonate 149 loperamide HCl 150 loratadine 151 lorazepam 152 lornoxicam 153 losartan potassium 154 lovastatin 155 loxoprofen sodium 156 manidipine HCl 157 medroxyprogesterone acetate 158 meloxicam 159 mequitazine 160 mesalazine 161 metformin HCl 162 methimazole 163 methocarbamol 164 methotrexate 165 methylphenidate HCl 166 methylprednisolone 167 metoclopramide HCl 168 metronidazole 169 microemulsion cyclosporine 170 midecamycin acetate 171 misoprostol 172 moexipril HCl 173 molsidomin 174 montelukast sodium 175 mosapride citrate 176 mycophenolate mofetil 177 nabumetone 178 nateglinide 179 neltenexine monohydrate 180 nicergoline 181 nicorandile 182 nifedipine 183 nimesulide 184 nimodifine 185 nitrendifine 186 nizatidine 187 norfloxacin 188 nortryptiline HCl 189 octylonium bromide 190 ofloxacin 191 olmesartan medoxomil 192 olopatadine HCl 193 omeprazole 194 orphenadrine HCl 195 oxcarbazepin 196 oxiracetam 197 paroxetine HCl 198 pentoxifylline 199 perphenazine 200 phenobarbital 201 phloroglucinol 202 pinaverium bromide 203 pioglitazone HCl 204 piroxicam 205 pranlukast hydrate 206 pravastatin sodium 207 prednisolone 208 procaterol HCl 209 proglumetacin maleate 210 propiverine HCl 211 propranolol HCl 212 propylthiouracil 213 pyrazinamide 214 quinupramine 215 rabeprazole sodium 216 ramipril 217 ranitidine HCl 218 rebamipide 219 repaglinide 220 rifampicin 221 risperidone 222 ropinirole HCl 223 rosiglitazone maleate 224 rosuvastatin calcium 225 roxatidine acetate HCl 226 roxithromycin 227 s-adenosyl-l-methionine sulfate-p-toluene sulfonate 228 <deletion> 229 simvastatin 230 sodium alendronate 231 sodium valproate 232 sofalcone 233 spironolactone 234 <deletion> 235 sulfasalazine 236 sulodexide 237 talniflumate 238 tamoxifen citrate 239 tamsulosin HCl 240 telmisartan 241 teprenone 242 terazosin HCl 243 terbinafine 244 thenothiola sodium 245 theophylline 246 tibolone 247 ticlopidine HCl 248 tipepidine hibenzate 249 tiropramide HCl 250 tizanidine HCl 251 tofisopam 252 tolperisone HCl 253 tolterodine tartrate 254 topiramate 255 torasemide 256 tramadol HCl 257 trazodone HCl 258 triamcinolone 259 triazolam 260 triflusal 261 trimebutine maleate 262 trimetazidine 2HCl 263 tripotassium dicitrato bismuthate 264 troxipide 265 ubidecarenone 266 valsartan 267 verapamil HCl 268 voglibose 269 warfarin sodium 270 zaltoprofen 271 zolpidem 272 α-lipoic acid 273 γ-linoleic acid [Attached Table 2] Expensive Pharmaceuticals Serial number Ingredient 1 5-hydroxytriptophan 2 abacavir sulfate 3 acitretin 4 adefovir dipivoxil 5 alfuzosin HCl 6 allylestrenol 7 altretamine 8 amisulpiride 9 anagrelide HCl 10 anastrozole 11 aripiprazole 12 atazanavir sulfate 13 atorvastatin calcium 14 auranofin 15 azasetron HCl 16 azathioprine