Regulations & Others

It takes about 12-15 years on average for a new drug to travel from the lab to patients. Pharmaceutical companies continuously test thousands of compounds to seek promising drugs. After preclinical study, ones of therapeutic value will induce the company to file an Investigational New Drug Application (IND). The manufacturer can begin the phase I development when the IND is approved by the FDA and by an Institutional Review Board. Once phase III is complete, the development enters the NDA stage. The FDA needs to obtain a broader range of advice on drug safety, effectiveness, and labeling. If approved, the drug may be marketed for disease treatment.

Overview of the US FDA drug-approval process Fig.1 Overview of the US FDA drug-approval process (Kim, 2012)

New Drug Research, Development, and Approval

Each year sees a couple of dozen new drugs licensed for use and the complexity in drug development has increased manifolds over the past few decades. The process of new drug discovery and development requires basic research, preclinical testing, investigational new drug (IND) applications, completed clinical testing, and marketing approval from the FDA. The research and development journey will have taken around 12 years and cost around $1.15 billion.

Orphan Drug Development and Regulation

Orphan drugs are used to treat diseases whose prevalence is below the rare disease threshold and may have other factors, such as a lack of alternative therapies. Because there is usually little understanding or information about the natural progression of the disease, developing drugs to treat rare diseases has many challenges. Regulatory policies for orphan drug development are already well established in the United States and Europe.

Pharmacy Compounding Regulation

Pharmaceutical compounding is the creation and dispensing of FDA-approved drug products in dosage delivery forms. It is an important part of healthcare and pharmacy practice. Due to the risks involved in the practice, compounding has come under increasing regulatory scrutiny. Currently, pharmaceutical compounding is regulated by both state authorities and FDA. However, this overlapping regulatory jurisdiction has caused uncertainty and controversy for regulators and pharmacy professionals.

Regulatory Authorities and Applications

With the development of pharmaceutical industries throughout the world, regulatory agencies and organizations play a vital role in drug development process. The regulatory agencies ensure drug compliance with various legal and regulatory aspects. Every country has its own regulatory body, which enforces rules and regulations, and issues guidelines regulating the drug development process, licensing, registration, manufacturing, marketing, and drug labeling.

Good Manufacturing Practice (GMP)

Good Manufacturing Practice (GMP) describes a set of principles and procedures followed to help ensure the high quality of therapeutic products. It contains minimum requirements for the facilities, methods, and controls used in the manufacture, processing, and packaging of pharmaceutical products. The FDA ensures drug quality by carefully monitoring drug manufacturers' compliance with their Current Good Manufacturing Practices (CGMP).

Pharmaceutical Marketing

Broadly speaking, pharmaceutical marketing is to make pharmaceutical products and care a reality, and available to customers. Marketing assists physicians in matching drug therapy to individual patient needs by providing an informed choice of carefully characterized agents. Pharmaceutical marketing is the most organized and comprehensive information system available to update physicians on the safety, availability, effectiveness, hazards, and use of medicines.


  1. Sapsford, K., Lauritsen, K. and Tyner, K., 2012. Current perspectives on the US FDA regulatory framework for intelligent drug-delivery systems. Therapeutic Delivery, 3(12), pp.1383-1394.
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