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Drugs and Health Products

Listing of Drugs Currently Regulated as New Drugs (The New Drugs List)

November 6, 2012

Notice

Our file number: 12-118879-948

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Contact: Policy Bureau Enquiries

The Therapeutic Products Directorate (TPD) has completed an assessment to determine whether the Listing of Drugs Currently Regulated as New Drugs (also known as the New Drugs List) should be updated or removed entirely from the Health Canada website. This is to notify sponsors that the list will not be updated to include any new substances or formulations. The 1999 version, with changes, will remain on the website since those substances and formulations have already been determined to be new drugs. The changes include: the deletion of one substance that was removed from the Canadian market due to safety reasons, the deletion of footnotes that are no longer applicable and the addition of footnotes identifying substances that were previously considered to be in new drug status but are now acceptable when used as a non-medicinal ingredient (NMI) in topical cosmetic-like drug products. The addition of footnotes will assist in decreasing the regulatory burden for stakeholders as well as to improve consistency in approaches between the TPD, the Natural Health Products Directorate (NHPD) and the Cosmetics Program.

Background:

The New Drugs List is an administrative list posted on the Health Canada website that represents substances or formulations in prescription and nonprescription drug products pursuant to an application to market. The list is used by TPD and external stakeholders as a guide in determining the type of submission to be filed pursuant to Division 1 only or Division 8 and the appropriate section of Division 1 in Part C of the Food and Drug Regulations for a subsequent market entry drug product.

The New Drugs List posted on the Health Canada website has not been updated since 1999. With the increasing workload and limited resources in TPD, updating and the annual maintenance of a list which is not all encompassing or up-to-date at any given time were not considered an efficient use of resources.

Sponsors currently have access to other sources on the Health Canada website to assist them in making drug status assessments for subsequent market entry drug products. For information on any new drugs approved since 1999, the Notice of Compliance (NOC) Listings and the Notice of Compliance (NOC) database can be used to determine whether the Canadian Reference product was granted market authorization through the issuance of an NOC. The approved Product Monograph in the Drug Product Database (DPD) can be consulted to determine the approved indication(s) for the reference product. If the information from these sources is not sufficient to make such an assessment, sponsors can submit a drug status request to the Regulatory Project Management Division servicing the applicable bureau to inquire what type of submission should be filed.

Questions regarding this notice should be directed to:

Bureau of Policy, Science and International Programs
Therapeutic Products Directorate
Health Products and Food Branch
Health Canada
1600 Scott Street
Holland Cross, Tower B
2nd Floor, Address Locator 3102C1
Ottawa, Ontario
K1A 0K9

Fax: 613-941-1812
E-mail: Policy_Bureau_Enquiries@hc-sc.gc.ca

Listing of Drugs Currently Regulated as New Drugs

This list represents substances and formulations which have been assessed by the Therapeutic Products Directorate on the basis of an application to market or further to promotion of products for medicinal purposes where safety and efficacy for such purposes have not been established. Certain substances have been considered to be new drugs regardless of their use as a medicinal or non-medicinal ingredient in drug products.

This listing is not all-encompassing due in part to the complexity of Division 8 of the Food and Drug Regulations. It should be used as a guide only in determining the status of subsequent market entry drug products.

"drug" includes any substance or mixture of substances manufactured, sold or represented for use in

  1. the diagnosis, treatment, mitigation or prevention of a disease, disorder, abnormal physical state, or its symptoms, in human beings or animals,
  2. (restoring, correcting or modifying organic functions in human beings or animals, or
  3. disinfection in premises in which food is manufactured, prepared or kept;

(Section 2 of the Food and Drugs Act )

"new drug" means

  1. a drug that contains or consists of a substance, whether as an active or inactive ingredient, carrier, coating, excipient, menstruum or other component, that has not been sold as a drug in Canada for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that substance for use as a drug;
  2. a drug that is a combination or two or more drugs, with or without other ingredients, and that has not been sold in that combination or in the proportion in which those drugs are combined  in that drug, for sufficient time and sufficient quantity to establish in Canada the safety and effectiveness of that combination and proportion for use as a drug; or
  3. a drug, with respect to which the manufacturer prescribes, recommends, proposes or claims a use as a drug, or a condition of use as a drug, including dosage, route of administration, or duration of action and that has not been sold for that use or condition of use in Canada, for sufficient time and in sufficient quantity to establish in Canada the safety and effectiveness of that use or condition of use of that drug.

(Division 8 of the Food and Drugs Regulations)

Please note: Unless otherwise indicated, all dosage forms and routes are included.

Substances which may otherwise be a Natural Health Product remain on the list as they would be considered a new drug if a submission is filed with Therapeutic Drugs Directorate (TPD) or if they are included in "Schedule 2-Excluded Natural Health Substances" of the Natural Health Products Regulations.

Revised

September 2012

Listing of new drugs
Drug Form/Route

Footnotes

Footnote 1

Amino acids are present in a protein configuration are not considered to be drugs; only when isolated and present as a single ingredient or in a configuration other than a completed protein is the drug/new drug status applicable.

Return to footnote 1 referrer

Footnote 2

This substance is not considered to be a new drug when used as a non-medicinal ingredient in topical cosmetic-like products if either of the two guiding principles are met or the data requirements are submitted and approved by Health Canada (see Appendix 1).

Return to footnote 2 referrer

Footnote 3

This substance, an omega-3 fatty acid, is present in fish oil and other food substances. It is to be regarded as a new drug only when intended as a therapeutic agent, when isolated/concentrated and sold as a single ingredient or added to other ingredients.

Return to footnote 3 referrer

Footnote 4

This substance is not considered to be a new drug when used in topical cosmetic-like products in a concentration up to 3% in "leave on" preparations and up to 10% "rinse off" formulations.

Return to footnote 4 referrer

Footnote 5

This substance is not considered to be a new drug when used as a non-medicinal ingredient in topical cosmetic-like products in a concentration up to 5%.

Return to footnote 5 referrer

Footnote 6

There is no known safe use of this substance. It is not acceptable as a non-medicinal ingredient at any level and is a new drug when associated with therapeutic claim(s).

Return to footnote 6 referrer

Footnote 7

This substance is considered to be a new drug (on the New Drugs List) because of the particular combination, form, route or indication. Each substance may not be considered to be a new drug when used as a non-medicinal ingredient in topical cosmetic-like products if either of the two guiding principles are met or the data requirements are submitted and approved by Health Canada (see Appendix 1).

Return to footnote 7 referrer

Acarbose  
Acebutolol and its salts  
Acetaminophen rectal suppository
Acetaminophen/Belladonna  
Acetaminophen/Butalbital  
Acetaminophen/Butalbital/Caffeine  
Acetaminophen /Butalbital/ Caffeine / Codeine  
Acetaminophen/Butalbital/Codeine  
Acetaminophen/Diphenhydramine (as asleep aid)  
Acetaminophen/Pseudoephedrine (for the treatment of earache)  
Acetylcysteine (mucolytic, antidote for acetaminophen poisoning)  
Acetylene/Carbon Monoxide/Methane/ Nitrogen/Oxygen  
Acetylsalicylic Acid (Anti-platelet)  
Acetylsalicylic Acid/ Diphenhydramine (as a sleep aid)  
Acitretin  
Acyclovir and its salts  
Adenosine and its salts Footnote 2  
Adapalene  
Alatrofloxacin and its salts  
Alclometasone and its salts  
Alfentanil and its salts  
Alkyl Salicylates Spray or Aerosol - as per I.L. 659
Allopurinol  
Alprazolam  
Alteplase  
Altretamine  
Amantadine and its salts  
Amcinonide  
Amikacin and its salts  
Amiloride and its salts  
Amino Acids
[Tryptophan, Arginine, Ornithine, Phenylalanine, Tyrosine, Lysine, Carnitine, Methionine (other than Lipotropic Factor)] Footnote 1
 
Amino Acids (Total Parenteral Nutrition Products) injection
Aminocaproic Acid  
Aminoglutethemide  
Aminophylline suppository, oral modified release preparation
Aminosalicylic Acid (5-)  
Amiodarone and its salts  
Amitriptyline/Perphenzine  
Amlodipine and its salts and esters  
Ammonium Chloride (single active ingredient)Footnote 2  
Ammonium Molybdate  
Amodiaquine  
Amoxicillin and its salts  
Amphotericin B  
Amrinone and its salts  
Anagrelide and its salts  
Anastrozole  
Apomorphine and its salts  
Apraclonidine and its salts  
Aprotonin  
Articaine and its salts  
Articaine HCl/Epinephrine  
Asparaginase Footnote 7  
Aspartates Footnote 2  
Astemizole  
Atenolol and its salts  
Atorvastatin and its salts  
Atovaquone  
Atracurium and its salts and esters  
Atropine and its salts oral tablet
Auranofin  
Azathioprine and its salts  
Azelaic Acid Footnote 4  
Azithromycin and its salts  
Aztreonam and its salts  
Baclofen and its salts  
Bambuterol and its salts  
Beclomethasone and its salts  
Benazepril and its salts  
Benzalkonium ChlorideFootnote 7/Boric Acid Footnote 7  
Benzoyl Peroxide/Erythromycin  
Benzoyl Peroxide/Titanium Dioxide Footnote 7  
Benzydamine and its salts  
Betahistine and its salts  
Betaine Anhydrous (for the treatment of homocystinuria)  
Betamethasone and its salts rectal enema, injection
Betamethasone Dipropionate/Clotrimazole  
Betamethasone/Gentamicin ophthalmic/otic
Betaxolol and its salts  
Bezafibrate  
Bicalutamide  
Biperiden and its salts  
Bismuth subcitrate (when used in combination to eradicate H. Pylori)  
Bisoprolol and its salts  
Bleomycin and its salts  
BoronFootnote 7 oral
Bretylium Tosylate  
Brimonidine and its salts  
Brinzolamide  
Bromazepam and its salts  
Bromocriptine and its salts  
Budesonide  
Bumetanide and its salts  
Bupivacaine and its salts  
Buprenorphine and its salts  
Bupropion and its salts  
Buserelin and its salts  
Buspirone and its salts  
Butenafine and its salts  
Butorphanol and its salts  
Caffeine Footnote 7/Ephedrine Footnote 7  
Calcipotriol  
Calcitonin Salmon Synthetic  
Calcitriol  
Calcium Acetate Footnote 7 (for the control of hyperphosphatemia)  
Calcium Carbaspirin  
Calcium Glycerophosphate Footnote 7 injection
Calcium Polystyrene Sulphonate  
Candesartan Cilexetil  
Capecitabine  
Caprylic Acid Footnote 2  
Captopril and its salts  
Carbamazapine  
Carbetocin  
Carbidopa and its salts  
Carbocysteine  
Carbon Monoxide/Methane/Nitrogen/ Oxygen  
Carboplatin  
Carboprost and its salts  
Carvedilol  
Cefaclor  
Cefadroxil  
Cefazolin and its salts  
Cefdinir  
Cefepime and its salts  
Cefixime and its salts  
Cefonicid and its salts  
Cefotaxime and its salts  
Cefotetan and its salts  
Cefoxitin and its salts  
Cefpodoxime and its salts  
Cefprozil  
Ceftazidime  
Ceftibuten Dihydrate  
Ceftizoxime and its salts  
Cefuroxime  
Centella Footnote 2  
Cephalexin (Monohydrate)  
Cephalothin and its salts  
Cerivastatin  
Cetirizine and its salts  
Chitosan Footnote 2  
Chloramphenicol tablet
Chloramphenicol/Hydrocortisone/Butoxyethylnicotinate topical
Chlordiazepoxide/Clidinium and its salts  
Chlorhexidine and its salts Footnote 7 oral rinse and dental solution
Chlormezanone  
Cholestyramine Resin  
Choline Theophyllinate  
Chondroitin and its saltsFootnote 2  
Chromic Chloride injection
Chromium Chloride Hexahydrate injection
ChymopapainFootnote 7  
Ciclopirox and its salts  
Cilazapril and its salts  
Cimetidine and its salts  
Ciprofloxacin and its salts  
Cisapride  
Cisatracurium and its salts  
Cisplatin  
Citalopram and its salts  
Cladribine  
Clarithromycin  
Clindamycin and its salts  
Clobazam and its salts  
Clobetasol and its salts  
Clodronic Acid and its salts  
Clofibrate  
Clomiphene and its salts  
Clomipramine and its salts  
Clonazepam and its salts  
Clonidine and its salts  
Clopidogrel and its salts  
Clorazepic Acid and its salts  
Clotrimazole  
Clozapine and its salts  
Co-enzyme Q-10 (other than as source of Co-enzyme Q-10 or Ubiquinone)Footnote 2  
Co-Trimoxazole  
Codeine Polistirex/Chlorpheniramine Polistirex  
Codeine Sulphate oral modified release
Colestipol and its salts  
Colfosceril Palmitate  
Coryceptin (Jing Ahi Dongchongxiacao)  
Cromolyn and its salts  
Cupric SulfateFootnote 7 injection
Cyclobenzaprine and its salts  
Cyclosporine  
Cyproterone and its salts  
Cytarabine and its salts  
Dacarbazine  
Dalteparin and its salts  
Danaparoid and its salts  
Danazol and its salts  
Dantrolene and its salts  
Dapiprazole and its salts  
Daunorubicin and its salts  
Deferoxamine and its salts  
Delavirdine and its salts  
Deprenyl and its salts  
Desflurane  
Desipramine and its salts  
Desmopressin and its salts  
Desonide and its salts  
Desoximetasone  
Devil's ClawFootnote 7 ( as anti-inflammatory/analgesic)  
Dexamethasone (in combination) ophthalmic / otic preparation
Dexfenfluramine and its salts  
Dexrazoxane  
DextranFootnote 7 liquid intravenous (IV)
Dextrothyroxine and its salts  
Diatrizoic Acid and its salts  
Diazepam  
Dibencozide  
Diclofenac and its salts  
Didanosine and its salts and derivatives  
Diethylpropion and its salts  
Diflucortolone and its salts  
Diflunisal and its salts  
Dihydroepiandrosterone (DHEA)
(Prasterone)Footnote 3
 
Dihydroergotamine and its salts nasal
Diltiazem and its salts  
Dimenhydrinate chewing gum
Dimethylglycine (DMG)Footnote 7  
Dimethyl Sulfoxide  
Dinoprostone  
Diphenidol and its salts  
Diphenoxylate and its salts  
Dipivefrin and its salts  
Dipyridamole  
Dirithromycin  
Disopyramide and its salts  
Divalproex and its salts  
Dobutamine and its salts  
Docetaxel  
Docosahexanoic Acid (DHA)  
Dolasetron and its salts  
Domperidone and its salts  
Dong QuaiFootnote 7  
Dopamine and its salts  
Doxacurium and its salts  
Doxapram and its salts  
Doxazosin and its salts  
Doxepin and its salts  
Doxorubicin and its salts  
Doxycycline and its salts  
Doxylamine Succinate (night time sleep aid)  
Droperidol and its salts  
Echothiophate Iodide  
Econazole and its salts  
Edetic Acid and its saltsFootnote 7 injection
Edoxudine  
Edrophonium and its salts  
Eicosapentaenoic Acid (EPA)Footnote 3,Footnote 7  
Electrolytes (Total Parenteral Nutrition Products)  
Emedastine and its salts  
Enalapril and its salts  
Enalaprilat and its salts  
Enflurane  
Enoxacin and its salts  
Enoxaparin and its salts  
Epirubicin and its salts  
Epoprostenol and its salts  
Erythromycin topical
Erythromycin (prophylaxis of neonatal chlamydial conjunctivitis) ophthalmic
Erythromycin Ethylsuccinate/Sulfisoxazole  
Esmolol and its salts  
Estazolam  
Estradiol and its salts  
Estramustine and its salts  
Estrogens / Progestogens  
Ethambutol and its salts  
Ethinyl Estradiol  
Etidronic Acid and its salts  
Etidronate Disodium/Calcium CarbonateFootnote 7  
Etodolac  
Etoposide and its salts  
Evening Primrose Oil  
Famciclovir  
Famotidine and its salts  
Fat Emulsion (Total Parenteral Nutrition Products)  
Felodipine and its salts  
Fenfluramine and its salts  
Fenofibrate  
Fenoterol and its salts  
Fentanyl and its salts  
Fenticonazole  
Ferulic AcidFootnote 2  
Fexofenadine and its salts  
Finasteride  
Flecainide and its salts  
Fleroxacin  
Floctafenine  
Fluconazole  
Flucytosine  
Fludarabine and its salts  
Fludrocortisone and its salts  
Flumazenil  
Flumethasone/Iodochlorohydroxyquin  
Flunarizine and its salts  
Flunisolide and its salts  
Fluocinolone and its salts  
Fluoride and its saltsFootnote 7  
Fluorometholone and its salts  
Fluorouracil  
Fluoxetine and its salts  
Flupenthixol and its salts  
Fluphenazine enanthate  
Fluphenazine decanoate  
Flurazepam and its salts  
Flurbiprofen and its salts  
Flutamide  
Fluticasone and its salts  
Fluvastatin and its salts  
Fluvoxamine and its salts  
Formestane  
Formoterol and its salts  
Foscarnet and its salts  
Fosinopril and its salts  
Fosphenytoin and its salts  
Furosemide  
Fusidic acid  
Gabapentine  
Gadodiamide  
Gadolinium  
Gadopentetate Dimeglumine  
Gadoteridol  
Galactose  
Galactose/Palmitic Acid  
Gallamine and its salts  
Gallium Nitrate and its salts  
Gamma Amino Butyric Acid (GABA)Footnote 4,Footnote 6  
Gamma Hydroxybutyric Acid (GHB)Footnote 5  
Gamma OryzanolFootnote 2  
Ganciclovir and its salts  
Gemcitabine and its salts  
Gemfibrozil  
Gentamicin Sulphate injection
Germanium  
Gestonorone Caproate  
GinsengFootnote 7  
GinsengFootnote 7/GuaranaFootnote 7/Bee pollenFootnote 7  
Glatiramer and its salts  
Gliclazide  
GlucomannanFootnote 2  
GlucosamineFootnote 2  
Glyburide  
Glycopyrrolate  
Gonadorelin and its salts  
Goserelin and its salts  
Gotu-Kola (see Centella)Footnote 2  
Granisetron and its salts  
Grepafloxacin and its salts  
Griseofulvin ultramicrosize tablet preparation
Halcinonide  
Halobetasol and its salts  
Halofantrine and its salts  
Haloperidol and its salts  
Haloprogin  
Halothane  
HeparinFootnote 7 topical
HyaluronidaseFootnote 7  
Hydralazine and its salts injection
Hydrochlorothiazide (in combination)  
Hydrocodone oral modified release preparation
Hydrocortisone rectal foam
Hydrocortisone - 17 - Valerate topical
Hydrocortisone/Allantoin topical
Hydrocortisone/Pramoxine rectal foam
Hydrocortisone/Urea topical
Hydromorphone and its salts modified release preparations, injection, immediate release spheroids
Hydroquinone/Retinoic Acid topical
Hydroxychloroquine Sulfate  
Hydroxycitric AcidFootnote 7  
Hydroxyurea  
Hyoscine Butylbromide  
Ibandronate  
Ibuprofen  
Idarubicin and its salts  
Imipramine and its salts injection
Imiquimod  
Indapamide Hemihydrate  
Indinavir and its salts  
Indomethacin  
Iodixanol  
Iodoquinol  
Iohexol  
Iopamidol  
Iopentol  
Iopromide  
Iothalamate Meglumine  
Iotrolan  
Ioversol  
Ipratropium and its salts  
Irbesartan  
Irinotecal and its salts  
Iron Dextran  
Isoflurane  
Isoproterenol and its salts oral inhalation
Isosorbide Dinitrate  
Isosorbide-5 Mononitrate  
Isotretinoin  
Isradipine  
Itraconazole  
Kava  
Ketamine and its salts  
Ketazolam  
Ketoconazole  
Ketoprofen and its salts  
Ketorolac and its salts  
Ketotifen and its salts  
Khat (Kat, Chat - Catha Edulis, Cathenone)  
Kojic AcidFootnote 7  
Kola Nitida  
Labetalol and its salts  
Lamotrigine  
Lansoprazole  
Latanoprost  
Letrozole and its salts  
Leucovorin and its salts  
Leuprolide and its salts  
Levamisole and its salts  
Levobunolol and its salts  
Levocabastine and its salts  
LevocarnitineFootnote 1,Footnote 2  
Levodopa and its salts  
Levofloxacin  
Levonorgestrel  
Levorphanol  
Lidocaine and its salts (antiarrhythmic agent)  
Lidocaine/Prilocaine  
Lidocaine hydrocloride (HCl) / Dextrose 5%
(antiarrhythmic agent)
 
Lidocaine HCl/ Norepinephrine Bitartrate  
Lincomycin and its salts  
Liothyronine and its salts  
Lisinopril and its salts  
Lithium and its salts  
Lodoxamide Tromethamine  
Lomefloxacin and its salts  
Loperamide and its salts  
Loracarbef  
Loratadine  
Loratadine/Pseudoephedrine  
Lorazepam  
Losartan and its salts  
Lovastatin  
Loxapine and its salts  
Mafenide and its salts  
Magnesium Pyrrolidone  
Malathion  
Maprotiline and its salts  
Mebendazole  
Meclofenamic Acid and its salts  
Medroxyprogesterone Acetate  
Mefenamic Acid and its salts  
Mefloquine and its salts  
Megestrol and its salts  
MelatoninFootnote 2  
MelatoninFootnote 2/Vitamin EFootnote 2  
Melphalan and its salts  
Mercaptopurine  
Meropenem  
Mesalamine  
Mesna  
Metaproterenol and its salts  
Metformin and its salts  
Methadone  
Methazolamide  
MethenamineFootnote 2  
MethenamineFootnote 2/Benzoic AcidFootnote 2/Sodium SalicylateFootnote 7  
Methimazole  
Methotrexate and its salts  
Methoxsalen  
Methyl SalicylateFootnote 2 spray
Methyldopate Hydrochloride injection
Methylprednisolone and its salts tablet, topical, injection
Metoclopramide and its salts  
Metolazone  
Metoprolol and its salts  
Metrizamide  
Metronidazole and its salts enema, vaginal gel, injection, topical
Mexiletine and its salts  
Miconazole and its salts  
Midazolam and its salts  
Midodrine and its salts  
Miglitol  
Milrinone and its salts  
Minocycline and its salts  
Minoxidil  
Misoprostol  
Mitomycin and its salts  
Mitoxantrone and its salts  
Mivacurium and its salts  
Moclobemide  
Mometasone Furoate  
Montelukast and its salts  
Morphine Sulphate modified release preparations, epidural
Mupirocin  
Mycophenolate Mofetil  
Nabumetone  
Nadroparin and its salts  
Nadolol and its salts  
Nafarelin and its salts  
Nafcillin and its salts  
Naftifine and its salts  
Nalbuphine and its salts  
Nalidixic Acid  
Nalmefene and its salts  
Naloxone and its salts  
Naltrexone and its salts  
Nandrolone and its salts  
Naproxen and its salts  
Naratriptan and its salts  
Nedocromil and its salts  
Nelfinavir and its salts  
Neomycin/Polymyxin B sterile irrigation
Nevirapine  
Nicardipine and its salts  
Niclosamide  
Nicotinamide  
Nicotine patch, gum
Nifedipine  
Nilutamide  
Nimodipine  
Nitrazepam  
Nitrofurantoin macrocrystals  
Nitroglycerin oral modified release, patch, ointment, injection, spray
Nizatidine  
Nonoxynol-9 [human immunodeficiency virus (HIV) claim]Footnote 7  
Norfloxacin  
Nortriptyline and its salts  
Nylidrin and its salts  
Nystatin/Zinc OxideFootnote 2  
Octacosanol  
Octreotide  
Octyl Methoxycinnamate/Oxybenzone/ Hydrocortisone  
Ofloxacin  
Olanzapine  
Olopatadine and its salts  
Olsalazine and its salts  
Omega-3 Fatty Acids, EPA and DHAFootnote 3  
Omeprazole  
Ondansetron and its salts  
Oral Contraceptives  
Orciprenaline and its salts  
Oxacillin and its salts  
Oxaprozin  
Oxazepam  
Oxiconazole and its salts  
Oxybutynin and its salts  
Oxycodone and its salts (as a single active ingredient)  
Oxymetholone  
Paclitaxel  
Pamidronic Acid and its salts  
Pancuronium and its salts  
Pangamic Acid and its salts  
Pantoprazole and its salts  
PapainFootnote 2  
Papaverine and its salts  
Paroxetine and its salts  
Pau D'Arco (Taheebo Tea)  
Penciclovir  
Penicillamine  
Pentamidine and its salts  
Pentastarch  
Pentazocine and its salts  
Pentosan Polysulfate Sodium  
Pentostatin and its salts  
Pentoxifylline and its salts  
Peppermint OilFootnote 2 enteric coated capsules
Pergolide and its salts  
Pericyazine  
Perindopril and its salts  
Permethrin  
Phentermine and its salts  
Phenylbutazone injection
Phenylephrine and its salts /Oxymetazoline and its salts  
Phenytoin and its salts oral
Picolinates  
Pilocarpine and its salts tablets
Pimozide  
Pinaverium and its salts  
Pindolol and its salts  
Piperacillin and its salts  
Pipotiazine and its salts  
Pirbuterol and its salts  
Piroxicam and its salts  
Plant SterolsFootnote 2  
Podofilox  
Podophyllotoxin  
Polynicotinates  
Porfimer and its salts  
Potassium CitrateFootnote 2  
Potassium FluorideFootnote 2  
Pramipexole  
Pravastatin and its salts  
Praziquantel  
Prazosin and its salts  
Prednicarbate  
Prednisolone and its salts oral syrup, injection
Prednisolone/Gentamicin ophthalmic
Prednisone oral solution
Prilocaine and its salts  
Probucol  
Procainamide and its salts  
Procarbazine and its salts  
Procaterol and its salts  
Prochlorperizine Edisylate  
Progesterone topical, capsules
Propafenone and its salts  
Propofol  
Propolis (for Herpes)  
Propoxyphene and its salts  
Propranolol and its salts  
Pyrazinamide  
Pyridostigmine Bromide tablet 30 milligram or any strength with nerve gas antidote claim, oral modified release tablet, injection
Pyrimethamine  
Quetiapine and its salts  
Quinacrine and its salts  
Quinapril and its salts  
Quinidine Bisulfate  
Quinidine Gluconate oral modified release preparation, injection
Raloxifene and its salts  
Raltitrexed and its salts  
Ramipril and its salts  
Ranitidine and its salts  
Remifentanil and its salts  
Retinoic Acid  
Reviparin and its salts  
Ribavirin  
Rifabutin  
Rifampin  
Rifampin/Isoniazid/Pyrazinamide  
Risperidone  
Ritonavir and its salts  
Rocuronium and its salts  
Ropinirole and its salts  
Ropivacaine and its salts  
Salbutamol and its salts  
Salcatonin  
Salicylic AcidFootnote 2/Corticosteroids  
Salsalate  
Sanguinarine (as antiplaque agent)  
Scopolamine HCl/Dihydroergotamine / Barbital/Phenobarbital/Butalbital Sodium  
Selegiline and its salts  
Selenious Acid  
Selenomethionine  
Sermorelin and its salts  
Sertraline and its salts  
Sevoflurane  
SiliconFootnote 2  
Silver NitrateFootnote 7 topical ointment
Silver Sulfadiazine  
Simvastatin and its salts  
Sodium Nitroprusside  
Sotalol and its salts  
Spectinomycin  
Spironolactone  
SqualeneFootnote 2  
Stannous FluorideFootnote 7 (for gingivitis/plaque)  
Stanozolol  
Streptokinase  
Sucralfate  
Sufentanil and its salts  
Sulbactam/Ampicillin  
Sulfadoxine  
Sulfamethoxazole/Trimethoprim  
Sulfasalazine  
Sulfinpyrazone  
Sulindac  
Sumatriptan and its salts  
Superoxide Dismutase (SOD)Footnote 7  
Tamoxifen and its salts  
Tamsulosin and its salts  
Tazarotene and its salts  
Temazepam  
Tenoxicam  
Terazosine and its salts  
Terbinafine and its salts  
Terconazole  
Terfenadine  
Terlipressin and its salts  
Testosterone and its salts transdermal, oral
Tetracycline and its salts dental floss
Tetrahydrocannabinols  
Thenoic Acid  
Theophylline oral modified release preparation
Thiabendazole  
Tiaprofenic Acid and its salts  
Ticarcillin and its salts  
Ticlopidine and its salts  
Tiludronate and its salts  
Timolol and its salts  
Tinzaparin and its salts  
Tioconazole  
Tixocortol Pivalate  
Tizanidine and its salts  
Tobramycin and its salts  
Tolbutamide  
Tolcapone  
Tolmetin and its salts  
Tolonium and its salts  
Tolterodine l-tartrate  
Topiramate  
Topotecan and its salts  
Toremiphene and its salts  
Torsemide  
Trace Elements (Total Parenteral Nutrition Products)  
Trandolapril and its salts  
Tranexamic Acid  
Tranylcypromine Sulfate  
Trazodone and its salts  
Tretinoin  
Triamterene  
Triazolam  
Trichloroacetic Acid  
TrichosanthinFootnote 7  
TriclosanFootnote 7 medicinal use in oral cavity
Trifluoperazine/Isopropamide  
Trifluridine  
Triglycerides-Medium chainFootnote 7 injectable
Trimebutine and its salts  
Trimeprazine and its salts  
Trimethoprim  
Trimetrexate Glucuronate  
Trimipramine and its salts  
Troglitazone and its salts  
Trovafloxacin and its salts  
Tryptophan (L-)Footnote 1,Footnote 2  
Ursodiol  
Valproic Acid and its salts  
Valsartan  
Vancomycin and its salts  
Vecuronium and its salts  
Venlafaxine and its salts  
Verapamil and its salts  
Vinblastine and its salts  
Vincristine and its salts  
Vinorelbine and its salts  
Vitamins-Multi (with claim for Total Parenteral Nutrition) injection
Warfarin and its salts (prophylaxis of systemic embolism after myocardial infarction)  
Yohimbine (aphrodisiac)  
Zafirlukast  
Zalcitabine and its salts  
Zidovudine  
Zinc Sulfate Heptahydrate injection
Zolmitriptan  
Zolpidem and its salts  
Zopiclone  
Zuclopenthixol and its salts  

Appendix 1

Guiding principles for substances on the New Drugs List which are not considered to be new drugs when used as non-medicinal ingredients in topical cosmetic-like drug products

Certain substances have been considered to be new drugs regardless of their use as a medicinal or non-medicinal ingredient and as a result, TPD has evaluated a number of substances on the 1999 New Drugs List. Substances used as non-medicinal ingredients in topical cosmetic-like drug products are not considered to be new drugs if they meet either of the following two guiding principles:

  1. If the substance is an active ingredient in a topical preparation (prescription or non-prescription), this substance will not be accepted as a non-medicinal ingredient (NMI) unless there is an authoritative review, such as that conducted by the Cosmetic Ingredient Review (CIR) expert panel that may have established threshold levels at, and below, which the substance can be safely used as an NMI.

  2. If the substance is listed as an acceptable and identical NMI in the Natural Health Product Ingredient Database (NHPID), and the acknowledged functions are consistent with that of non-medicinal ingredient functions in cosmetics, such as a skin conditioning, film former, antioxidant, light/formulation stabilizer, etc.

Note:

  • restrictions for any ingredient listed on the Cosmetic Ingredient Hotlist are applicable.
  • unless otherwise specified, the concentration of all substances as well as Standard of Manufacture must be in compliance with the Good Manufacturing Practices (GMP) as outlined in Division 2 of the Food and Drug Regulations.

Requirements for  substances used as non-medicinal ingredients in cosmetic-like products that are considered to be New Drugs (on the New Drugs List) if either of the two guiding principles are not met or the substance has not been previously assessed by Health Canada.

The following requirements to be submitted to Health Canada as a Drug Identification Application (DINA) are:

  1. A cover letter identifying the substance and a rationale using the two guiding principles or alternatively, a justification of why it should not be considered a new drug when used as a non-medicinal ingredient in a topical cosmetic- like drug product;

  2. The justification may include the following information for each substance, if applicable, but not limited to:
    1. Confirmation of its role as a pharmaceutical excipient [for example (e.g.), in The Handbook of Pharmaceutical Excipients, The Cosmetic Ingredient Identification Database, The European Cosmetic Ingredients Database, The Personal Care Products Council, Cosmetic Ingredient Identification Database, the CosIng (European Cosmetic Ingredients Database) or review by the International Pharmaceutical Excipients Council)];
    2. Evidence in support of the concentration at which the NMI would not have any therapeutic effect but would have well-documented cosmetic attributes, such as a moisturizer;
    3. Evidence in support of the concentration at which the NMI safety profile has been established for the target population and the topical route of administration. This evidence should demonstrate that percutaneous absorption is such that there is no risk of systemic toxicity even under conditions of potential misuse as well as local tolerance studies [e.g., irritation and sensitization in the presence and absence of ultraviolet (UV) light];
    4. Limitation, if any, provided for the ingredient on the Cosmetic Hotlist;
    5. Approval of its inclusion as an excipient or non-medicinal ingredient by other regulatory agencies [e.g., Therapeutic Goods Administration (TGA), United States Food and Drug Administration (FDA), European Medicines Agency (EMA)] that is based upon internationally accepted scientific standards; and

  3. Any additional information or material respecting the proposed use of the substance as an NMI that is considered to be pertinent.

To obtain more information on the data requirements, it is strongly recommended that the sponsor request a pre-submission meeting with the appropriate review Bureau to discuss any questions or issues they may have. Alternatively, a sponsor can file a Drug Identification Number Application (DINA) to Office of Submissions and Intellectual Property of TPD.