In recent times, the emergence of nitrosamine impurities in certain generic drug substances has prompted a re-evaluation of industry practices. This blog takes a deep dive into the multifaceted world of nitrosamine mitigation, specifically in the context of generic drug products. Moreover, it also throws light upon considerations made for Nitrosamine Drug Substance Related Impurities. We explore the intricacies of maintaining quality, ensuring bioequivalence, and understanding the pivotal role of regulatory experts in this critical process.

The United States Food and Drug Administration (US FDA) released guidance in December 2022, a revision of the guidance titled ‘Failure to Response to an ANDA Complete Response Letter (CRL) Within the Regulatory Timeframe Guidance for Industry,’ of July 2022. It is meant to guide the applicants of Abbreviated New Drug Applications (ANDAs) submitted under section 505(j) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(j)). A complete and relevant response to a CRL is crucial for the approval of the generic drug.

The introduction of high-quality and reasonably-priced generic drugs in the market is a prevalent challenge for multiple Health Authorities. Several countries are taking steps to address this issue and make more generic drugs available in the market, consequently increasing the competition at a global level.

DYK? The National Medical Products Administration (NMPA), along with China National Intellectual Property Administration (CNIPA), has released “Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)." It is a patent registration platform for chemical drugs, biological products, and traditional Chinese medicines. Along with this, the measures will also help by offering opportunities for market approval based on registered patents and judgment outcomes for chemical entities.

Competitive generics are known to be a boon as they pave the way to a lucrative market, provided drug manufacturers can decode the challenging and complicated drug development. Although drug development technologies are constantly evolving, we are yet to comprehend the outcomes of Competitive Generic Therapy (CGT). When we discuss the disease burden, the size and volume of the patient population demography have been critical elements for drug development and its approval.

The National Medical Products Administration (NMPA) of China recently released a comprehensive draft amendment for implementing the China Drug Administration Law (DAL). 

The draft amendment introduces significant changes to the Regulatory framework. It encodes the various Regulatory initiatives undertaken by the Chinese government since the implementation of the current China DAL, which was promulgated in 2019. The Law was intended for data protection and patent linkage.  

Advance Therapy Medicinal Products (ATMPs) are novel drugs that meet patients’ specific needs. But they drastically increase the cost of treatment. Generic alternatives provide relief in terms of treatment cost with a quality drug of similar effectiveness.

In 2023, about fifty-one (51) drugs will get off-patented in the United States, opening the gates for generic drugs to claim a share of the expected expired drugs. Tracking the expiration of these drugs will help assess business opportunities and refine market entry strategies. As a result, pharmaceutical organizations should understand the criticality of Abbreviated New Drug Application (ANDA) submissions and ensure that the documents submitted have additional information about the medicinal product for review by the competent Health Authority.

Recently, the FDA published three (03) guidance documents that focus on generic drug application submissions, labeling, and review. Among the three (03) guidance documents, two (02) are final drafts, and one (01) is a revised draft, which supports FDA’s Drug Competition Action Plan (DCAP) that was first announced in 2017. The guidance documents are a part of the FDA’s continued effort to bring greater efficiency and transparency to the generic drug review process, which helps spur competition and improves consumer access to medicines at affordable prices. Let’s dive into the details.

While innovators or branded drug products carry additional costs associated with the research and development of the product from the molecule identification stage to post-market authorization, generic drug products are relatively cost-effective. These therapies not only reduce the overall cost of treatment, but also significantly improve patient access to life-saving drug products.