Pharmaceutical Education, University Education , other training, experience in the pharmaceutical industry and relevant skills are the main determinants of a successful career in regulatory affairs. Careful plan is required in acquiring the right blend of these elements . It’s possible to waste a lot of time not doing things that add value to competence […]
ECTD publishing jobs in Canada are not as many as in USA although there are many qualified personnel around. Most of these jobs are found in Ontario and Quebec. Activities related to eCTD publishing in Canada are usually taken up by regulatory affairs personnel than designated eCTD publishers.
Education and Training for eCTD Publishing
Generally a Bachelor’s […]
Regulatory agencies employ different eCTD validation rules to to ensure that all dossiers meet the same regulatory standards. In this article I will discuss some eCTD validation rules used by Health Canada in relation to PDF documents , hyperlinks and bookmarks.
Validation Software and eCTD Validation Rules
There are several types of eCTD Validation software. They may […]
The sequence folder contain all the ectd information. When you submit an application for market authorization Regulatory agencies such as Health Canada apply certain validation rules to determine compliance with the eCTD guidelines. Your submission will not be accepted unless it complies with the guidelines. Submitting an eCTD dossier is team work. Several people will […]
A product licence is required for the sale of Natural Health Products(NHPs) in Canada unless you are a retailer. You are not allowed to sell a natural Health product without a product licence even if you claim its doctor formulated as I have seen lately.
If the licence is cancelled or suspended, you are not allowed […]
The main obligation of Importers of natural health products to Canada is to comply with Natural Health Products GMP requirements. The purpose of these requirements is to ensure that imported products meet the same quality, safety and efficacy standards as locally manufactured products.
1.What Standards should imported products meet?
The regulations place an important the responsibility on […]
There are different types of generic pharmaceuticals meeting various patients’ medical needs. Some treat rare diseases such as the prescription only injection of zoledronic acid used to prevent fractures in patients with prostate cancer or multiple myeloma.
Others such as acetaminophen treat common disease such as pain. Not all diseases have an equivalent generic pharmaceutical. Generic […]
Breakthrough treatment designation was intended to speed up the development and review of drugs to treat conditions that are serious or life-threatening. A sponsor must provide preliminary clinical evidence to support the claim for a breakthrough treatment designation. The required evidence should be able to demonstrate that the drug may be a significant improvement over […]
FDA fast Track designation is one of the methods CDER uses to speed up the creation and increase the approval of novel drugs. Along with it the following methods are also used.
•Priority Review,
•Breakthrough, and
•Accelerated Approval process.
How FDA fast track designation helps to speed up drug development
A process is followed to determine if a drug merits […]
Good clinical practice training is essential for anyone involved in testing medicines on human volunteers. Good Clinical Practice (GCP) is an ethical and practical standard for the protection of the welfare of all clinical study participants including the integrity of the data collected.
Who needs Good clinical practice training
All the personnel involved in any way during […]
