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Creating compliant packaging for a cosmetic product is a collaborative effort of various departments in an organization such as: Labeling, Artwork and Regulatory Affairs. While label artwork must be validated by an artwork labeling team, it must combinedly be reviewed and approved by Regulatory Affairs team to ensure the compliance.
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Artwork services for the current Consumer Healthcare/Food Supplements landscapes are divided as per the markets. For Compliance based markets, artworks are created by Freyr team and submitted to the client for finalizing the artwork/ label.
The current medical device landscape has turned challenging for manufacturers in terms of ensuring quality and audit compliance due to ever-evolving regulations which may lead to extended time for approvals and market access.
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.
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).
The National Medical Products Administration (NMPA) of China recently released a comprehensive draft amendment for implementing the China Drug Administration Law (DAL).
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.
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.
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.
To note, there are many gaps in the Regulatory science that need to be addressed for the development and evaluation of medicine. Global Regulatory Agencies make strong efforts to close these gaps and enable access to innovative medicines that address the patient’s needs.
A new report from a European generics trade association says that extreme cost-containment policies can adversely affect the generics supply chain vide consolidation of generics drug production and withdrawal of such products from the market.
Supply chain challenges across the globe have laid bare the inefficiencies of the distribution system framework amidst the pandemic. Considering its enduring impact on the global pharmaceutical market, better operational structure and resilient operational framework are the basis for seamless manufacturing requirements in hindsight.
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