Drugs | Regulatory Affairs

Pharmaceutical Regulatory Services

Understanding Pharmaceutical Drugs

Pharmaceutical drugs are either synthetic products made from chemicals or made from Biological

substances. They are meant to improve the health and well-being of patients by helping to prevent

and treat disease, reduce pain and suffering, and extend and save lives.

Some higher-risk drugs, such as those used to treat diseases, require a prescription from a physician.

Other lower-risk drugs, such as cough syrup and antacids, are sold without a prescription and

are readily available to the public. These drugs are considered low risk and are generally considered as Over the Counter (OTC) Drugs

Innovator drugs ("brand name drugs"): Manufacturers receive authorization to sell these products in Canada by submitting a New Drug Application

Subsequent entry drugs ("generic drugs"): Regulators around the world often authorize manufacturers to market drugs that are copies of the original innovator drug by requiring them to submit an Abbreviated version of a New Drug Application. There is a patent period of 8-10 years after the which the generic version of the drug can enter into the market.

Just give a call or send us an email with all your questions and we will be glad to assist. We will typically answer you in 3-4 business days. We are there to assist you in all your Regulatory Requirements. We will first determine if your drug is a Prescription or an OTC Drug. We will next accordingly compile, file and submit your submissions as per the required Regulations for both OTC and Prescription drugs. We have compiled some of the most Frequently asked questions that may answer many of the queries you may have.

What are Pharmaceutical Drugs?

Pharmaceutical drugs are either synthetic products made from chemicals or made from Biological substances. They are meant to improve the health and well-being of patients by helping to prevent and treat disease, reduce pain and suffering, and extend and save lives.
Why do some drugs require a Prescription whereas others do not?

Some higher-risk drugs, such as those used to treat diseases, require a prescription from a physician. Other lower-risk drugs, such as cough syrup and antacids, are sold without a prescription and are readily available to the public. These drugs are considered low risk and are generally considered as Over the Counter (OTC) Drugs
What are the different types of drugs available?

Innovator drugs ("brand name drugs"): Manufacturers receive authorization to sell these products in Canada by submitting a New Drug Application Subsequent entry drugs ("generic drugs"): Regulators around the world often authorize manufacturers to market drugs that are copies of the original innovator drug by requiring them to submit an Abbreviated version of a New Drug Application. There is a patent period of 8-10 years after the which the generic version of the drug can enter into the mardket.
How are drugs regulated in Canada?
Authorization procedure for Drugs sold in the Canadian market.

All Drugs that fall under the Division 8 of the Food and Drug Regulation (Part C) are approved as a New Drug Submission (NDS). After the patent tenure expires, generic companies are eligible to submit drugs with a similar formulation as an Abbreviated New Drug Submission (ANDS). All submissions are done by using a Common Technical Document (commonly called as an eCTD). After an administrative screening period of 45-50 days, the scientific review of Quality, Clinical and Non-Clinical data takes place. This takes around 300 days. The total New Drug Submission (NDS) approval timeline is around 350 days. So it will be almost a year for a New Drug to be approved. ANDS is much faster as Preclinical and clinical data are not required to establish their safety and efficacy. Contact us to discuss your regulatory needs and we will prepare an extensive checklist of all the requirements you need to get your product authorized to be sold in Canada.
What is the cost of the approval Process.

Health Canada charges a fee for Examination of Submission of Drugs for Hunam use. This fee can be seen here. This fee depends on the type of submission and whether the application is for a New Drug that is not previously approved in Canada. Cost for Examination of Prescription and Non Prescription Drugs, Disinfectants, Drug Identification Number- Labelling Standards and Administrative reviews vary. Contact us and we will let you know the most upto date information on the Fees charged by Health Canada.
How are Drug Application Files sent to Health Canada?

All Drug application files whether it is a Prescription or OTC drugs are sent in Electronic Common Technical Document Format. It is imperative to get a company id from Health Canada, following which a dossier id is to be obtained. Sponsors are encouraged to use a commercially available tool to validate their regulatory transactions in eCTD format, prior to filing them to Health Canada. We as consultants have all the tools to establish a validated eCTD format. Contact us for more details. We have a validated software that ensures that all aspects of the Validation rules are met. Click here to check out the Validation rules published by Health Canada
What is a Generic Drug

A generic drug is a copy of a brand name drug. The generic drug is pharmaceutically equivalent to the brand name drug: it contains the identical medicinal ingredients, in the same amounts and in a similar dosage form. Generic medications may have different non-medicinal ingredients than the brand name drug, but the company must show that these do not affect the safety, efficacy, or quality of the drug compared to the brand name drug.
A brand name drug has just been introduced, after how many years is a Generic version of the same drug allowed?"

The first step is to find out when the patent of the Brand name drug expires and thiscan be found from the Patent Register published by Health Canada.Many new brand name drugs are innovative drugs and also have 'data protection', which means there are regulations that give them a period of market exclusivity. Health Canada cannot approve a generic copy of innovative drugs for at least 8 years. Health Canada often authorizes manufacturers to market these drugs by requiring them to submit an Abbreviated New Drug Submission (ANDS) pursuant to section C.08.002.1 of the Food and Drug Regulations. These products will receive a declaration of bioequivalence to a Canadian Reference Product (pursuant to Section C.08.004 (4)), which will be stated on the NOC. Contact us to start your application for a Generic Drug.
What is a Notice of Compliance?

A Notice of Compliance is a notification, issued pursuant to paragraph C.08.004(1)(a), indicating that a manufacturer has complied with sections C.08.002 or C.08.003 and C.08.005.1 of the Food and Drug Regulations. Notices of Compliance are issued to a manufacturer following the satisfactory review of a submission.
What are the main requirements for an OTC drug and are there any identifying features?

Non-prescription drugs require a valid Drug Identification Number (DIN) to be sold in Canada. On a product label, this number indicates the drug has met the requirements for: safety, quality and effectiveness.
What is the Code of Federal Regulations

The Code of Federal Regulations is a codification of the general and permanent rules published in the Federal Register by the Executive departments and agencies of the Federal Government. The Code is divided into 50 titles which represent broad areas subject to Federal regulation. Each title is divided into chapters which usually bear the name of the issuing agency. Each chapter is further subdivided into parts covering specific regulatory areas. For example, the specific regulation covering drug GMPs appears as "21 CFR 211", that is, Title 21, Part 211. Regulations enforced by FDA are found in volumes 1-8 of Title 21, parts 1-1299. They are updated as of April 1 of each year. The Federal Register and the CFR must be used together to determine the latest version of a given rule.
What are the types of warning letters that you can receive from the US FDA

The FDA typically issues warning letters when manufacturers violate major rules and regulations. There are 3 types of warning letters that you may receive:- 1) FDA 483 Observation Notice 2) General warning letter 3) Close out letter