What is ICH and Why? ICH stands for International Council for Harmonization. To be more precise, it is The International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use. ICH is established in 1990. It started as a group of Pharma/Biotech Industry and Regulatory Agencies such as FDA from USA, Europe and Japan to discuss and harmonize scientific and technical aspects of drug registrations. Now, there are many other countries that joined ICH […]
Art of Searching for FDA Forms for Regulatory Professionals
Regulatory Professionals need to work with FDA Forms on a daily basis whether they are dealing with an Investigational New Drug Application (IND) or New Drug Application (NDA) or Biologics License Application (BLA) or Abbreviated New Drug Applications (ANDA) or any device clearance applications. Our general instinct is to search for an FDA form on google. But sometimes google tend to show an outdated form. For example, my search for Form 1572 yielded the below […]
One thing that FDA looks into before it allows to test drugs in humans and how.
FDA or any regulatory authority takes Safety first approach when dealing with drugs. They do not want to risk any human lives. Hence, a drug is studied in several hundreds if not thousands of patients before it is approved. That one thing that FDA looks into before it lets companies test drugs in humans is “Safety” of the drug. How is it that FDA do not want to give approval before testing it in patients […]
The Three Pillars of Dug Development
In my last article, we discussed about the “Public Health” as a single most major responsibility of FDA or any health authority. In the same article, we also saw several mission statements of different regulatory authorities including FDA, Health Canada and MHRA. For example, FDA’s mission statement reads something like this: “The Food and Administration is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological […]
What is the Major Responsibility of any Health Authority
The single major responsibility of any Health Authority/Drug Regulatory Authority is to protect the health of its public. Remember the term: PUBLIC HEALTH That is also a reason why majority of drug regulatory authorities are nested under “Department of Health” within their Country. For example: So, how do these authorities protect the public health? Let us look into the mission statements of some of these agencies to get a better idea: First Paragraph of United States FDA Mission says: “The […]
Regulatory Authority or Health Authority?
After I started working in Regulatory Affairs, I started noticing that we use regulatory authority and health authority interchangeably when talking about organizations such as FDA, Health Canada or MHRA (the organizations to which we generally submit drug applications for various purposes). What is the difference between both terms? Can we really use them interchangeably? Is there a time when we should specifically use “Health Authority”? Regulatory Authority is a government agency that regulates businesses […]
What is Regulatory Affairs
Before I started my career full time in Regulatory Affairs, my view of it is that Regulatory Affairs gets involved in multiple areas of drug development and as someone who has experience in different areas, i felt it would be a perfect fit for me. But I started pondering about “What is Regulatory Affairs” not until someone asked me what do I do and what it means?. I realized I never articulated it for myself. […]
Introduction to Regulatory Buddy
Drug development is a technically deep field with so many moving parts. Regulatory Affairs is like a Core that holds all these parts together and liaise between the sponsor (or a company developing the drug) and Regulatory Agencies (Eg: FDA in US; MHRA in UK) to protect the health of public by providing safe and efficacious drugs. Regulatory affairs professionals are involved in reading a lot: Regulations, laws, guidance documents etc. A lot of patience […]