Who are they?
Drug regulatory agencies or authorities are responsible in effective drug regulation to ensure the safety, efficacy and quality of drugs, as well as the accuracy and appropriateness of the drug information available to the public.
The most highly regulated industries worldwide are Pharmaceuticals. These agencies or authorities ensure the compliances in legal and regulatory aspects in a drug. They are responsible to enforce the rules and regulations to regulate drug development process, licensing, registration, manufacturing, marketing and labeling of Pharmaceutical products.
Reasons for regulation by agencies:
Regulatory agencies were started to address the issues raised in efficacy and safety of drugs and to oversee development and marketing of drug products.
Use of any drug carries with it some degree of risk of an adverse event. For most drugs the risk-to-benefit ratio is favorable; i.e., the benefit derived from using the drug far outweighs the risk from its use. However, there have been unfortunate circumstances in which drugs have caused considerable harm. The harm has come from drug products containing toxic impurities, from drugs with unrecognized severe adverse reactions, from adulterated drug products, and from fake or counterfeit drugs. So, effective drug regulation is required to ensure the safety and efficacy of drugs for the general public.
Objectives of drug regulatory agencies / authorities
Important functions include:
- Review of the submitted drug dossiers.
- Evaluation of safety and efficacy data from animal and clinical trials.
- Inspection and licensing of manufacturing facilities.
- Monitoring of adverse drug reactions for investigational and marketed drugs
Types of Administration of drugs:
- Tablets – the most common dosage form. Taken through the oral route of administration. They are made by compressing powdered drug.
- Capsules– They are filled with powder or granules. Taken through the oral route of administration.
- Other solid dosage forms– They include powders, lozenges, and suppositories.
- Liquid dosage forms – They are either solutions or suspensions of active drug in a liquid [Syrup].
- Semisolid dosage forms– They are ointments and creams.
- Specialized dosage forms– Nasal sprays.
- Parenteral dosage forms– Injections or infusions. Common injection types are intravenous (Vein), subcutaneous (Skin) and intramuscular (Muscle). Infusions by intravenous route. Parenteral dosage forms must be sterile. If they are given intravenously, they must readily mix with blood.
Drug approval processes
Drug approval processes is required to allow safe and effective drugs to be marketed. Drug regulatory agencies /authorities in various countries attempt to rely on premarketing scientific studies of the effects of drugs in animals and humans in order to determine if new drugs have a favorable risk-to-benefit ratio.
Although most countries require similar types of pre-marketing studies to be completed, differences in specific regulations and guidelines exist. Thus, if pharmaceutical firms wish to market their new drugs in many countries, they face challenges created by the differing regulations and guidelines for pre-marketing studies. Additional safety or efficacy studies may be required in few cases.
Drug applications
The Investigational New Drug [IND] will provide information about the drug, dosage form, summaries of animal studies. IND application is required for approval to begin studies of a new drug in humans. Clinical trials for new drugs are conducted prior to marketing as part of the development process.
Human clinical studies:
Phase-1 studies describe the first use of a new drug in humans to determine the pharmacological [Study of the interactions between drugs and the body] and pharmacokinetic [Study of the rates and extent of drug absorption, distribution within the body, metabolism, and excretion] profile of the drug and to assess the adverse effects associated with increasing drug doses.
Phase-2 studies involve several hundred patients.
Phase-3 studies involve several hundred to thousand patients and are designed to collect data concerning both adverse events and efficacy.
After completion of all the 3 phases, the data will be reviewed to judge whether the drug can be marketed or not?.
Prior to its regulatory approval, a drug is generally restricted to use in patients who are formally enrolled in a clinical trial. In some cases, a drug that has not yet been approved for marketing can be made available to patients with a life-threatening disease for whom no satisfactory alternative treatment is available.
New Drug Application [NDA]
NDA is the next requirement of FDA. NDA is a detailed report about the new drug of the following:
- Chemistry, manufacturing, and dosage forms.
- Animal pharmacology and toxicology.
- Human pharmacokinetics.
- Results of clinical trials.
- Testing methods.
- Microbiology [For Steriles].
- Proposed labeling.
Post marketing adverse drug events
The pharmaceutical company is responsible for reporting adverse drug events to the drug authorities on a regular basis. Identifying adverse drug events is not always easy. Monitoring of adverse drug events is critical for the long term evaluation and usage of the drug by the public.
Drug patents
The patent allows the Pharmaceutical manufacturer to be the only company to market the drug in the country. During the patent period, the patented drug will have no direct market competition.
All drugs have brand names created by the companies that develop them. All drugs also have generic names. After the expiry of the patent, other companies may market the drug under its generic name or under another brand name.
The brand name is the name given by the company that makes the drug and is usually easy marketing purposes. The generic name, on the other hand, is the name of the active ingredient.
E.g, Paracetamol is the generic name while Crocin / Metacin etc. are brand names.
Once the patent expires, other manufacturers duplicate and market their own versions of the drug. The manufacture of these generic drugs do not involve a repeat of the extensive clinical trials to prove their safety and efficacy.
The only requirement is to demonstrate that the new version is biologically equivalent to the already approved drug. Bioequivalent drug products have the same rate and extent of absorption and produce the same blood concentration of drug when the two drugs are given in the same dose and in the same dosage form.
When a Pharmaceutical manufacturer submits a generic drug for marketing approval, they submit an Abbreviated New Drug Application (ANDA) instead of a full NDA. In an ANDA, the applicant is claiming that their drug is a duplicate of an already-approved drug.
Future scope
More centralized procedures in drug regulation.
Harmonization of regulatory norms.
Strengthening the regulatory authorities
Note-The images given for representation in this blog are taken from Google Images. Many thanks for Google.