Publicity regarding the publication of the List of (First Batch) with clear clinical value and inability to recommend reference preparations.

Release Date: 20200827. In accordance with the "Announcement on the Implementation of The Evaluation of the Quality and Efficacy of Injection Imitations" issued by the National Bureau on May 14, 2020 (No. 62 of 2020), our Center has selected the List of Drugs (First Batch) with Clear Clinical Values that Cannot Recommend Reference Preparations (see Annex), which is now published on the Center's website. Welcome from all walks of life to put forward valuable comments and suggestions, and please give us timely feedback. Publicity period: August 27, 2020 - September 9, 2020. Contact us at [email protected]. Drug Review Center of the State Drug Administration. August 27, 2020.

Annex 1: The clinical value is clear and it is not possible to recommend a list of chemicals for reference preparations (batch No. 1) (draft for comments). Annex 2: Request feedback form.docx.

1

This Translation made by Global Regulatory Partners Inc was made to be used as a helpful resource and should not be used as an official translation of regulatory content.

The list of Drugs exempted from BE Studies

(in the first batch) (draft for comments).

Serial The generic name of the drug. Dosage form. 1 Amino acid glucose injection. Injections. 2 Sodium acetate ringer injection (with sodium acetate Injections.

3 Low calcium peritina dialysis solution (lactate- Injections. ii ) 4 Second sodium propylene sodium injection. Injections. 5 Fluorine(18F) is more injectable than his class. Injections. 6 Fluorine(18F) sodium oxide injection. Injections.

7 Fluorine (18F) Lobepin injection. Injections. 8 Fluorine(18F) deoxygluose injection. Injections. 9 Compound sodium acetate electrolyte injection. Injections. 10 Complex electrolyte glucose MG3 injection. Injections. 11 Complex electrolyte injection (including II-III-V. V. ) Injections.

12 Compound sodium chloride injection. Injections. 13 Compound lactic acid sodium sorbitol injection. Injections. 14 Peritonal dialysis solution (lactate-containing type) Injections. 15 Glycol injection. Injections. 16 Sodium lysate is injected. Injections. 17 Mix sugar electrolyte injections. Injections. 18 Sodium sulfate injection. Injections. 19 Potassium chloride injection. Injections. 20 Sodium chloride injection. Injections. 21 Injection of potassium-magnesium mendonate. Injections. 22 Potassium mendonate injection. Injections. 23 Sodium potassium magnesium calcium glucose Injections.

24 Sodium chloride injection. Injections. 25 Sodium chloride injection of glucose. Injections.

2

This Translation made by Global Regulatory Partners Inc was made to be used as a helpful resource and should not be used as an official translation of regulatory content.

Serial The generic name of the drug. Dosage form. 26 Sodium chloride injection of calcium glucosate. Injections. 27 Glucose injection. Injections. 28 Sodium lactic acid ringer injection. Injections. 29 Sodium bicarbonate ringer injection. Injections. 30 Sodium bicarbonate injection. Injections.

31 Vitamin B12 injection. Injections.

32 VitaminB 1 injection. Injections.

33 Vitamin B6 injection. Injections. 34 injection. Injections. 35 Waterless ethanol injection. Injections. 36 Children's compound electrolyte injections. Injections. 37 Hydrochloric injection. Injections. 38 Water for injection. Injections. 39 Convert sugar electrolyte injections. Injections. 40 Convert sugar injections. Injections. 41 Anaminophen deoxynephrine tablets. Tablets. 42 Coenzyme Q10 tablets. Tablets. 43 Compound aminophen renin tablets. Tablets. 44 Compound digestive enzyme tablets. Tablets. 45 Polycapo non-calcium tablets. Tablets. 46 tablets. Tablets. 47 Phosphoric acid canine tablets. Tablets. 48 Sulphuric acid morphine tablets. Tablets. 49 Zinc sulfate tablets. Tablets. 50 Aluminium magnesium plus chewing tablets. Tablets. 51 Glucose electrolyte foam flakes. Tablets. 52 Calcium glucosate tablets. Tablets.

Calcium carbonateD 3 chewing tablets (containing 53 Tablets. calciumcarbonate D 3 chewing tablets II).

54 Calcium carbonateD 3 tablets. Tablets. 55 Calcium carbonate chewing tablets. Tablets.

3

This Translation made by Global Regulatory Partners Inc was made to be used as a helpful resource and should not be used as an official translation of regulatory content.

Serial The generic name of the drug. Dosage form. 56 Sodium bicarbonate tablets. Tablets.

57 ViD2 calcium phosphate chewing tablets. Tablets. ViD calcium chewing tablets (including children's 58 Tablets. vitamin D calcium chewing tablets)

59 Vitamin B1 tablets. Tablets.

60 Vitamin B2 tablets. Tablets.

61 Vitamin B6 tablets. Tablets. 62 Vitamin C foam tablets. Tablets. 63 Vitamin C tablets. Tablets. Hydrochloric morphine tablets (slow release tablets 64 Tablets. containing hydrochloric acid morphine) 65 Folic acid flakes (0.4mg) Tablets. Complex polyethyl glycol electrolyte dispersion (I- 66 Powder. II-III.IV) III., IV) 67 Polyethyl glycol sodium potassium dispersion. Powder. 68 Oral Rehydration Salt Dispersion (I-II-III) Powder.

Calcium carbonateD 3 particles (including calcium 69 Particulate agent. carbonate D3 particles). 70 Wheat cellulose particles. Particulate agent. Right methafin more invasive glycerother swallows 71 Particulate agent. particles. The more invasive glyceroether swallows the 72 Particulate agent. particles. 73 Aminophen softgels. Capsules. 74 Aminol meth softgel. Capsules. 75 Coenzyme Q10 capsule. Capsules. 76 Treatment with iodine(131I) sodium oxide capsules. Capsules. 77 Amino glucose oral solid preparation. Oral solid i 78 Acetaminophen dry suspension agent. Dry suspension. 79 Oral solution of phenylalanine. Oral solution. 80 An oral solution of aminophen safin. Oral solution. 81 Oral solution of amino nephrin. Oral solution.

4

This Translation made by Global Regulatory Partners Inc was made to be used as a helpful resource and should not be used as an official translation of regulatory content.

Serial The generic name of the drug. Dosage form. 82 Compound ammonia meth oral solution. Oral solution. 83 Compound hydrobromobromoic acid right methafin Oral solution.

84 Compound zinc iron calcium oral solution. Oral solution. 85 Oral solution of sodium phosphate. Oral solution. Calcium glucosate oral solution (containing compound 86 Oral solution. calcium glucosate oral solution) 87 Oral solution of calcium glucosate zinc. Oral solution. 88 New oral solution of hemophenol bromine. Oral solution. 89 Fumaric acid iron suspension. Mixed suspension. 90 Aluminum magnesium mixed suspension. Mixed suspension. 91 Multi-dimensional lysine syrup. Syrup. 92 Mefinamide ammonium syrup. Syrup. 93 Children's hydrobromobromoic acid right methafin Membrane agent. b 94 Polyethylene alcohol eye drops. Eye preparations. 95 Sodium chloride eye drops. Eye preparations. 96 Hydroxyglyceride glycelin eye drops. Eye preparations. 97 Aseptic water eye wash. Eye preparations. Right-hand glyceride hydroxypropylene cellulose 98 Eye preparations. drops. 99 Compound polyciscosin B ointment. Emulsion. 100 Hydroquinone cream. Emulsion. 101 Mint brain gel. Gel. 102 Kapom production channel gel. Gel. 103 Benza chlorammonium solution. Solution. 104 Anticoagulant blood with sodium acid solution. Solution. 105 Balanced salt solution (for perfusion) Solution. 106 Chloroporamine solution of glucosic acid. Solution. 107 Blood preservation fluid (I) Solution. 108 The blood filters the replacement base fluid. Solution. 109 Kaiserus (including complex Kaiserus) enemas. 110 Hydrated chloralal enema. enemas.

5

This Translation made by Global Regulatory Partners Inc was made to be used as a helpful resource and should not be used as an official translation of regulatory content.

Serial The generic name of the drug. Dosage form.

111 Rinse fluid for cerebrospinal surgery. Rinse agent.

112 Balance the salt rinse. Rinse agent. 113 Sorbitol Glycol Rinse (Sorbitol Glycol Rinse) Rinse agent. 114 Methyl nitrosamine chlorohisitamine wasosterone. Lotion. 115 Inhale a solution of sodium chloride. Inhale the solution. 116 Willow camphor. The agent.

117 Oxygen. Gas.

Undelievers not listed in China shall be subject to the relevant requirements of the original General Administration Notice No. 230 of 2015, and the Note. generic name and dosage form of the drug shall prevail after approval by the Pharmacopeia Commission.

6

This Translation made by Global Regulatory Partners Inc was made to be used as a helpful resource and should not be used as an official translation of regulatory content.