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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.
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.
As per the recent update from the Danish Medicines Agency (DMA) dated October 19, 2022, the deadline for submitting marketing authorization and clinical trial applications has been revised to December 20, 2022. The move comes as the DMA will be closed from December 24 to January 01, 2023, for the Holiday Season.
Companion Diagnostics (CDx) are In Vitro Diagnostic devices used in conjunction with therapeutic drugs to determine their suitability for the patients. To place the CDx in the European Union, the manufacturer is required to submit technical and other relevant documents to the Notified Body (NB) for technical and conformity assessment.
Developing novel and essential medicinal products has significantly increased the burden of monitoring and tracking the Adverse Drug Reactions (ADRs) and Adverse Events (AEs) of drug products. An Individual Case Study Report (ICSR) is collected at an individual level, which leads to causality assessment or a tilt in the risk-benefit ratio of a medicinal product to be determined distinctly.
In 1999, the European Medicines Assessment Agency (EMEA) and the European Federation of Pharmaceutical Industries and Associations (EFPIA) set out to design a new system to share product information electronically to support the submission of new products or variations post-approval. This was called Product Information Management (PIM), which was withdrawn in 2011.
To market medicinal products in the European Union (EU) countries, pharmaceutical companies must prepare and translate documents like the Summary of Product Characteristics (SmPCs), Patient Information Leaflets (PILs), and product labels in twenty-four (24) EMA-approved languages.
The prime goal of a Health Authority (HA) is to promote and protect the interests of those it serves by amending and introducing new regulations. The European Medicines Regulatory Network (EMRN) is a network of competent authorities that work in sync to draft guidance documents that regulate medicines while upholding the standard of the medicinal products being authorized.
The journey of a drug product doesn’t end with its post-market authorization. The drug’s performance is now openly evaluated by the general population. To safeguard the population against any undesirable outcomes, post the consumption of a drug, a pharmacovigilance alert system is in place.
Unmet Medical Need (UMN) is one of the most pressing priorities of health systems. Constantly evolving science and technology around healthcare has harbored the potential to explore various therapeutic options. Health Authorities encourage innovative therapies that promise significant benefits to patients' quality of life.
On February 09, 2022, the European Medicines Agency (EMA) commenced the establishment of a Coordination Centre for Data Analysis and Real-World Integration Network (DARWIN EU®). It is the first step towards integrating Real-World Evidence (RWE) into assessing medicines across the European Union (EU).
The European Medicines Regulatory Network (EMRN) has adopted a common electronic Product Information (ePI) standard for human medicines. The common ePI standard was one of the major projects undertaken by the European Medicines Agency (EMA), the National Competent Authorities (NCA), and the European Commission (EC).
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