~ Regulatory Affairs ~
Canadian and American Regulatory Affairs Consultancy Service
Mr. T. B. (Tim) Airey A.Sc.T. of Calgary, Alberta, Canada has ten years of experience in Canadian and American regulatory affairs consultancy work. Formerly in association with Bio-Chem Consulting Services Ltd. of Calgary, this regulatory work specialises in pharmaceutical, dietary supplement, traditional herbal medicine, food product and cosmetic submissions. These submissions are to such federal government agencies as the American Food and Drug Administration (FDA), Health Canada�s Therapeutic Products Programme (TPP) and the Canadian Food Inspection Agency (CFIA).
All submissions - Canadian Drug Identification Numbers (DINs), American National Drug Codes (NDCs) and CFIA food label reviews - include label design and layout (draft form only) and, where applicable, French translation (for Canadian submissions). Many submissions have been made on behalf of German companies. The label design for such submissions may include translation and modification of the original German text to French and/or English. The import products from Germany were intended for both the Canadian and US markets.
The primary focus for this type of work is to enable Canadian companies to import - or American companies to export - products to Canada from the USA. However, considerable experience has also been accumulated with respect to the regulations and procedures governing the importation of products from Europe (principally Germany) for sale in both the Canadian and American domestic markets.
Background and Experience:
Mr. Airey has been providing the pharmaceutical, dietary supplement, herbal, food, cosmetic and related industries with a full range of regulatory affairs, quality control (QC), quality assurance (QA) and consulting services since the early nineties. In this capacity, he has gained an extensive degree of experience in working with - and interpreting the demands of - the several North American regulatory agencies such as the American Food and Drug Administration (FDA), the National Institute for Occupational Safety and Health (NIOSH), the Canadian Food Inspection Agency (CFIA) and the Therapeutic Products Programme (TPP) - a division of Health Canada.
In addition, a knowledge and understanding of the requirements of both the American and Canadian Good Manufacturing Practice (GMP), the United States Pharmacopeia (USP), The Canadian Food and Drugs Act and Regulations and Consumer Packaging and Labelling Act as well as access to the latest TPP regulatory publications, allows him to offer a first-class consultancy service to prospective American, Canadian and European clients.
Regulatory Affairs:
Government Liaison: Mr. Airey has an excellent working relationship with various Health Canada regulatory agents, and, as a consequence, is fully able to represent his clients� requirements and best interests to the various government agencies (FDA, TPP, CFIA, etc.). This relationship is of prime importance when dealing with the government in regard to product registration (DIN & CDR submissions) or in regard to site audits of manufacturing plants, independent quality control laboratories, warehousing or distribution sites, etc.
DIN Submissions: Expertise has been acquired in the preparation and submission of applications for Drug Identification Numbers (DINs) on behalf of several Canadian, American and European companies importing pharmaceuticals, nutritional supplements, traditional herbal medicines or related products into Canada. Often, for these companies, applying on their own behalf for a DIN (or making other submissions) can be a time-consuming and often frustrating process. Bio-Chem Consulting�s expertise in these areas is an invaluable aid to both the Canadian importer/manufacturer and to similar American or off-shore companies.
NDC Submissions: Expertise has also been acquired in applying for National Drug Code numbers (NDCs) on behalf of several Canadian and German companies exporting drug products into the United States.
Labelling: All products must be labelled in accordance with the requirements of the appropriate government agency: All OTC drug products, dietary supplement and herbal products must have labels that conform to TPP regulations. Food products must comply with the Canadian Food Inspection Agency (CFIA) regulations, and for these types of product, a draft label must be submitted to the CFIA for a formal label review. Bio-Chem Consulting has extensive experience in label design and layout for all of these types of products.
For drug products, an acceptable label design - either in draft or finished form - is an important component of the DIN application process. Failure to provide the appropriate information in sufficient detail - for either the DIN application or the label - can seriously hinder the processing of a submission. In order to help prevent these delays, our office pre-screens the product labels and recommends changes prior to a formal submission. In the majority of DIN submissions, Bio-Chem Consulting�s regulatory experts are able to design and submit the label on behalf of the client.
Establishment Licensing: An establishment license is now required for all businesses involved in activities relating to the manufacturing and testing of all Schedule C and D drugs in dosage form (and bulk intermediates). Bio-Chem Consulting can assist (including fee schedules and general compliance) any business, involved in these areas, with this latest requirement from the TPP.
Cosmetics Products: Cosmetics are subject to the provisions of the Food and Drugs Act and Regulations regarding composition, safety, labelling and advertising, as well as being subject to the Consumer Packaging and Labelling Act and its regulations regarding bilingual labelling, etc. The Cosmetic Regulations of the �Act� require that a Cosmetic Notification Form be submitted to the Health Protection Branch (HPB) prior to importation of a cosmetic, or within 10 days of first sale if the product is manufactured in Canada.
Bio-Chem Consulting is familiar with the Cosmetic Guidelines and requisite labelling requirements and has experience in these types of submissions. In addition, we have also made similar submissions to the Cosmetic Programs and Regulations Branch of the FDA in the United States. Note: In May of 1998, Bio-Chem Consulting was invited by the Product Safety Bureau of Health Canada to submit views and comments on the proposed review of the regulations governing the safety of cosmetic products in Canada.
Veterinary Products: These products also require a Drug Identification Number (DIN) and are subject to the same �Acts� as cosmetics. Our familiarity with the Guide for the Labelling of Drugs for Veterinary Use, as well as our experience in the design and lay-out of label drafts, has enabled Bio-Chem Consulting to file a number of DIN submissions on behalf of our clients.
Traditional Herbal Medicines: Bio-Chem Consulting Services Ltd. has a growing and unique expertise in the rapidly expanding and increasingly regulated field of Traditional Herbal Medicines (THMs). As the popularity of self-medication by traditional means increases, the Therapeutic Products Programme (TPP) - a division of Health Canada - is becoming more involved in regulating this industry. In this regard, the TPP has recently released an appendix to the 4th addition of the GMP specifically relating to the manufacture of herbal drug products.
Current TPP policy respecting THM continues to evolve and change. There are frequent new publications available from the Drugs Directorate; for example, Guidelines for THM, Labelling Standards, and individual Herbal Monographs are just some of the types of documents that provide expanded guidance and written clarification of current policy relating to THM. The requirements of the various documents become effective immediately upon publication, and this adds to the complexity of an actual DIN submission. Bio-Chem is one of the few consulting companies in Canada specializing in the herbal medications area.
Submissions for multi-ingredient herbal products can be particularly complex. Importers, especially, can be caught unawares with products that contain unacceptable levels or types of medicinal or non-medicinal ingredients. Labelling standards require that no unacceptable claim be made for a product, that the intended pharmacological effects are clearly stated, and that the dosage regime is presented in clear precise lay terms. For each herbal ingredient, the submission must include at least two acceptable references (each containing a complete monograph).
Suitable references are quite difficult to obtain, and to this end, Bio-Chem has been gathering the best pharmacopoeias, general herbals, and other sources of herbal monographs to expand our reference library. Additionally, we have immediate access to the latest status decisions, ingredient policy statements, toxicological information and general requirements regarding THMs from Health Canada.
In this regard - and in regard to the whole area of Natural Health Products (NHPs) - Bio-Chem Consulting is continuing to monitor the changes towards a more comprehensive regulatory policy stemming from the work outlined in the Final Report of the Advisory Panel on Natural Health Products (a regulatory framework for NHPs) issued by Health Canada.
The Advisory Panel recommends fundamental changes to the both the Food and Drugs Act and, indeed, to the whole regulatory administrative system. The new framework will include - in addition to THMs, dietary supplements, etc. - all conventional foods, supplements, functional foods, nutraceuticals, and other therapeutic products sold in dosage form and marketed as natural health products for human use.
Quality Control:
In association with Bio-Chem Consulting Services Ltd. (an independent quality control laboratory), a full range of practical laboratory services can be supplied for the client. Included among these are stability testing (shelf life studies), uniformity of dosage units (a test that determines the uniform potency of a products ingredients from tablet to tablet or capsule to capsule) and dissolution testing (a procedure that determines if a tablet will dissolve quickly enough in the human digestive system). In addition, Bio-Chem Consulting can perform microbial testing and screening, method development and routine product and raw material testing (for potency and active ingredient identification).
These specialized laboratory services are performed on a wide range and variety of product types including over-the-counter (OTC) drugs, traditional herbal medicines (THMs), dietary supplements (multi-vitamin, mineral and herbal preparations), skin care products (barrier creams, lotions, ointments, cleansers, etc.), safety products (eye & skin flushing solutions, antiseptic creams, etc.), veterinary products and biocide disinfectants.
OTC Drugs: Bio-Chem Consulting's laboratory staff analyze the active ingredients in a variety of OTC products including analgesics, cough medicines, cough drops, throat lozenges, antacids, medicated liniments, first-aid creams, antiseptic skin cleansers, medicated skin care products, eye wash, hard surface disinfectants, counterirritants and topical anesthetics. The active ingredients of these products are assayed using our own in-house developed (or USP-modified) High Performance Liquid Chromatography (HPLC) and Atomic Absorption (AA) methods.
Dietary Supplements: Bio-Chem Consulting has had many years of continuous involvement with the analysis of vitamins and minerals in dietary or vitamin/mineral supplements-type products. In their capacity as a QC laboratory, their expertise in this field has increased to the point where they are now analyzing (assay, potency, stability, uniformity, dissolution and microbial limits testing) a full range of vitamin and multivitamin-mineral products of various dosage forms. In addition, we have developed an expertise in the analyses of a variety of fish-oils and other vegetable-based oils for vitamins D2 and D3 content respectively.
With respect to the analyses of vitamin D2 (Ergocalciferol) and D3 (Cholecalciferol), Bio-Chem Consulting has built up a unique position in Western Canada regarding the development and performance of these difficult and time-consuming analyses. Indeed, over the years, they have developed their own multi-step method for the analysis; however, although this method has been developed to suit their client�s unique requirements, it is still based upon the standard USP method (USP XXIII).
Quality Assurance:
Bio-Chem Consulting Services Ltd. adheres to the latest requirements of the Good Manufacturing Practice (GMP) - 1998 Edition. This was developed by Health Canada's Therapeautic Products Programme (TPP) in partnership with the National Pharmaceutical Science Group and in consultation with the pharmaceutical manufacturing associations, provincial governments, health professionals, and other regulatory bodies. This Edition brings the GMP into greater agreement with international GMP standards, such as those of the World Health Organization, the European Community, the Pharmaceutical Inspection Convention, and the United States FDA.
The mandate of a first-class QA/QC facility should be to achieve - on behalf of their clients - the design and implementation of a suitable quality control system for the safe and efficacious manufacture of a finished product.
This system must encompass all major stages of manufacturing and sale from raw material inspection to product distribution. It will include all production and in-process controls; container and labelling requirements; finished product quarantine, testing, and release; and shipment to warehousing and distribution points. Also, any such system will include ancillary considerations such as sanitation and hygiene requirements; premises and equipment inspection, upkeep and maintenance; training and qualifications of all supervisory, laboratory, and plant personnel.
In addition to the foregoing - and as an overriding consideration to all of the above - is the often daunting task of initiating and maintaining the requisite �paper trail.� This must be implemented, maintained, and kept in a professional and orderly manner in order to facilitate any government audit. Specific documentation (Plant Master Files, Standard Operating Procedures, etc.) is required for each stage of production and quality control, as well as for the overall plant operation. All documentation must adhere to strict internal and external controls and inspections. Bio-Chem Consulting has assisted clients with these concerns and is experienced in setting-up the documentation.
Bio-Chem Consulting Services Ltd. offers a unique and all-encompassing QA/QC service to pharmaceutical, nutraceutical, cosmetic, food, herbal medicine and related manufactures as well as to the importers and distributors of these products.
Contact Information:
E-mail: [email protected] or [email protected], or [email protected]
Phone: (403) 253-7026 (bus) or (403) 242-0854 (home)