A New Chemical Entity (NCE) refers to the discovery of new compound in the pharmaceutical industry. This compound has a novel structure, possibly a new chemical class that the innovator has discovered. NCE also implies that such a compound is entirely new and has never been approved for medical use by any regulatory authority worldwide. The discovery of an NCE is a significant milestone in developing new medications, as it serves as the basis for further research, development, and clinical trials to assess its therapeutic potential. An NCE is defined as a drug that contains no active moiety previously approved by any regulatory authorities in the world. Innovator drug manufacturers typically develop an NCE during the early stages of the product cycle. The NCE then undergoes various clinical trials to become a drug product eventually.
In 2015, the FDA issued a draft guidance stating that if an NCE is approved for a drug product under section 505(b), no other manufacturer can apply for a product with the same active moiety for five years from the approval date of the original drug product. However, the guidance also includes an “Umbrella Policy,” allowing products developed simultaneously with the same active moiety to share the five-year exclusivity period. This exclusivity, granted by the FDA, gives the license holders a competitive advantage in the market. The five-year exclusivity applies to each drug substance present in the product. NCE exclusivity can be obtained by submitting either a 505(b)(1) or 505(b)(2) application.
New Chemical Entities (NCEs) are the driving force behind innovation in drug development, opening new treatment possibilities where current therapies fall short or are unavailable. All NCEs do not necessarily develop into potential medicines; they need to undergo rigorous developmental work in chemical, pharmaceutical, toxicological, pharmacological and clinical evaluations.
The development process for an NCE is rigorous, involving multiple stages to ensure its safety and effectiveness for human use.
- Initially, the compound undergoes extensive in vitro (test tube) and in vivo (animal) studies to evaluate its pharmacological properties, toxicity, and potential side effects. This preclinical testing is essential for identifying any significant risks before moving on to human trials.
- Once preclinical testing is successful, the NCE progresses to the clinical trial phase, where it is tested in humans to assess safety, efficacy, and optimal dosing. Clinical trials are conducted in phases, each designed to answer specific research questions: Phase I trials focus on safety and dosage, Phase II trials assess efficacy and side effects, and Phase III trials confirm the drug’s effectiveness, monitor side effects, compare it to standard treatments, and gather information to ensure its safe use.
- Regulatory authorities like the U.S. Food and Drug Administration (FDA) or the European Medicines Agency (EMA) play a crucial role in the development of NCEs. They review data from preclinical and clinical trials to evaluate whether the benefits of the NCE outweigh its risks. Upon approval by the regulatory authority, the NCE can be marketed as a new drug, offering patients new treatment options.
In summary, New Chemical Entities (NCEs) are at the forefront of developing innovative and effective treatments for diseases that were previously unmanageable or incurable. Many NCEs have significant revenue-generating potential and contribute to improving access to healthcare. They drive continuous research and development to enhance patient outcomes and lead to further pharmaceutical advancements. While developing NCEs is a complex and expensive process, the substantial benefits they offer to public health and medical knowledge confirm their tremendous value.