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

November 6, 2012

Notice

Our file number: 12-118879-948

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of one substance that was removed from the Canadian market due to safety reasons, the deletion of footnotes that are no longer applicable and the addition of footnotes identifying substances that were previously considered to be in new drug status but are now acceptable when used as a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 saltsFootnote 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
AsparaginaseFootnote 7
AspartatesFootnote 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 AcidFootnote 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 AcidFootnote 7
Benzoyl Peroxide/Erythromycin
Benzoyl Peroxide/Titanium DioxideFootnote 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
CaffeineFootnote 7/EphedrineFootnote 7
Calcipotriol
Calcitonin Salmon Synthetic
Calcitriol
Calcium AcetateFootnote 7 (for the control of hyperphosphatemia)
Calcium Carbaspirin
Calcium GlycerophosphateFootnote 7 injection
Calcium Polystyrene Sulphonate
Candesartan Cilexetil
Capecitabine
Caprylic AcidFootnote 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
CentellaFootnote 2
Cephalexin (Monohydrate)
Cephalothin and its salts
Cerivastatin
Cetirizine and its salts
ChitosanFootnote 2
Chloramphenicol tablet
Chloramphenicol/Hydrocortisone/Butoxyethylnicotinate topical
Chlordiazepoxide/Clidinium and its salts
Chlorhexidine and its saltsFootnote 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 3Footnote 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 4Footnote 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 1Footnote 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 2
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 1Footnote 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.

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