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

November 6, 2012

Notice

Our file number: 12-118879-948

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of one substance that was removed from the Canadian market due to safety reasons, the deletion of footnotes that are no longer applicable and the addition of footnotes identifying substances that were previously considered to be in new drug status but are now acceptable when used as a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
2^nd 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

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.