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How New Chemical Entities (NCEs) Drive Pharmaceutical Innovation

The pharmaceutical industry is constantly changing, and staying informed is critical to the long-term viability of organizations involved in the sector. New Chemical Entities (NCEs) are emerging pharmaceutical compounds representing the forefront of industry innovation and biotechnology trends. This article explores NCEs, why they are essential, and how they can impact your business. 

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What are New Chemical Entities (NCEs)?

New Chemical Entities, or NCEs, are emerging drug substances or pharmaceutical compounds containing active moieties previously unapproved by regulatory agencies like the European Medicines Agency (EMA), the United States Food and Drug Administration (FDA), or any international counterpart.

Understanding Active Moieties

Every medicine intends to produce a therapeutic effect. An active moiety is the specific chemical component within the drug that creates this effect. 

Moieties are identifiable and distinct components of molecules. The term specifically refers to a specific chemical subunit or functional group within the larger molecule or compound that determines the chemical and biological properties of the molecule.

For example, moieties can be functional groups, such as amino (-NH2), hydroxyl (-OH), carboxyl (-COOH), or another arrangement of atoms that relay specific chemical properties to a molecule. In the case of the molecule ethanol (CH3CH2OH):

  • The hydroxyl (-OH) group is a moiety
  • The methyl group CH3 contributes to the molecule’s overall structure
  • The methylene group CH2 adds more carbon atoms and contributes to the molecule’s structure

The moiety typically binds to a specific receptor or enzyme in a drug molecule. Researchers use this concept to break down the molecules of the compound to gain a better understanding, which is essential to studying the structure-activity relationship of all molecule components.

Identifying moieties is also critical to chemical nomenclature and naming conventions because they describe the compound’s structure by identifying its functional groups and subunits.

Along with -OH, other common moieties include:

  • Amino Group (-NH2) – a nitrogen atom bonded to two hydrogen atoms. Amino groups are a characteristic feature of amines, amino acids, and proteins.
  • Carbonyl Group (C=O) – a carbon atom double-bonded to an oxygen atom found in various compounds, including ketones, aldehydes, and carboxylic acids.
  • Carboxyl Group (-COOH) – a combination of a carbonyl group and a hydroxyl group that is a feature of carboxylic acids.
  • Phosphate Group (-PO4) – consists of a phosphorus atom bonded to four oxygen atoms and is critical to the function of biological molecules like DNA, RNA, and ATP. 
Methylene Blue

How NCEs Impact API and Pharmaceutical Intermediates Suppliers

APIs and pharmaceutical intermediates are typically required for the production of NCEs. As NCEs move towards approval, their demand may increase. Suppliers of APIs and pharmaceutical intermediates can capitalize on this demand by following the market closely. 

Additionally, API and intermediates suppliers and customers should consider diversifying product offerings to include specific compounds required for NCE manufacturing. Further, suppliers should ensure that their product offerings meet strict quality and regulatory standards, such as Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP).

The Significance of NCEs on the Pharmaceutical Landscape:

NCEs are critical to the pharmaceutical industry for several reasons:

NCEs lead pharmaceutical innovation.

NCEs typically lead new drug innovation by driving extensive research and development efforts aimed at discovering new drugs. They can also potentially improve patient care by addressing unmet medical requirements or offering more effective therapies.

Granting exclusive periods to NCEs protects research companies.

Manufacturers of NCEs typically receive a period of exclusivity from regulatory agencies of around five years. Exclusive periods protect manufacturers by prohibiting other companies from producing and distributing generic versions of drugs containing the same active moiety. 

NCEs provide market opportunities.

NCEs can generate significant market opportunities for pharmaceutical companies as they move through the development pipeline and reach regulatory approval.

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GMP-certified products are produced and controlled according to standards set by regulatory authorities and relevant industry organizations. 

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GMP is a mark of quality. Compliance with GMP standards ensures products are manufactured to high standards, including consistency, equipment, employee training, testing, and facility design. 

GMP-certified products undergo robust quality control and testing procedures to ensure they are consistent, safe, and effective. This is absolutely critical for substances intended for human consumption. 

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GMP is recognized worldwide as the leading standard for producing and distributing APIs. Many regulatory authorities, including the European Medicines Agency (EMA), and the US Food and Drug Administration (FDA) require GMP compliance for product approval and marketing.

GMP covers the entire supply chain to make sure your products are top quality from start to finish, including raw material sourcing, storage, and transportation. Choosing GMP-certified APIs ensures supply chain integrity and reduced risk of poor-quality, counterfeit, or contaminated products.

About MedicaPharma

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Different countries and jurisdictions may have varying regulatory requirements, with poor enforcement of relevant rules and regulations. There may be accountability and transparency issues associated with manufacturing and distribution, which increases your risk of receiving non compliant products. 

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Learn more about New Chemical Entities

New Chemical Entities (NCEs) are at the forefront of pharmaceutical innovation, bringing new medicines to patients while generating business opportunities in the API and pharmaceutical intermediates sector. 

Staying informed about NCE developments and understanding their impact on the pharmaceutical business is critical to your long-term success. MedicaPharma is an EU-based pharmaceutical distribution partner that collaborates with universities and research institutions to provide GMP-certified APIs and pharmaceutical intermediates. 

Contact us to learn more about new chemical entities and how to leverage them in your organization.

New Chemical Entities FAQ

New Chemical Entities (NCEs) are crucial to pharmaceutical innovation by leading the development of new and improved therapies. New medicines potentially address unmet medical needs and improve treatment outcomes.

NCEs are newly developed compounds with unique chemical structures and therapeutic effects. In contrast, generic drugs are replicas of previously approved patented, brand-name drugs that contain the same active ingredients. Generic drugs typically come to market once the exclusivity period for the NCE expires.

Yes, NCEs are available to patients upon regulatory approval from an agency such as the European Medicines Agency (EMA) or the Federal Drug Administration (FDA). Typically, they are costlier during the exclusivity period, and availability may be affected by healthcare provider preferences and insurance coverage.

The exclusivity period for new chemical entities is usually five years in the United States and eight years in Europe. During this time, the drug manufacturer has exclusive rights to sell the therapeutic, and other companies are prohibited from producing and distributing generic versions of the NCE.

Once the exclusivity period expires, other manufacturers, including generic drug producers, can develop and distribute generic versions of the NCE. As a result, competition for the drug increases, which typically reduces the price.

NCEs typically undergo a comprehensive regulatory approval process that includes preclinical testing, clinical trials, and regulatory reviews by the European Medicines Agency (EMA) or the Federal Drug Administration (FDA). Approval of the NCE is granted based on efficacy and safety data.

Contact MedicaPharma to learn more about how new chemical entities can affect your business, including exclusive periods and purchasing opportunities.

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