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Regulatory Rules, Opinions & Thoughts
Global Labeling Management

Global Labeling Management Roadblocks Disquieting the Efficiency of Pharma Companies

Labeling, Regulatory Operations

The accelerated introduction of new regulations and guidelines for pharmaceutical labeling industry during past few decades, demands companies to be pro-active in terms of the implementation lifecycles. The dire consequences associated with the erroneous label on a drug or a medical device accounts to severe health risks for the patients. Physicians rely on the label […]


Streamlined Regulatory Procedures for Successful Compliance

Streamlined Regulatory Procedures for Successful Compliance

Regulatory Affairs, Upcoming Mandates

The key to achieve Excellence in Pharma In an endeavor to reach the end user within the shortest timelines, drug manufacturers / organizations sometimes might miss out certain must-to-follow Regulatory procedures, thus hindering the Compliance efforts, required product registrations and market authorizations. In addition, using legacy applications and systems add-on to the worries of incompatibility, […]


CDRH’s Top 10 Regulatory Science Priorities

CDRH’s Top 10 Regulatory Science Priorities for FY 2017

Upcoming Mandates

The influence on Medical Device’s Regulatory Decision Making Centre for Devices and Radiological Health (CDRH), a division of US Food and Drug Administration (FDA) seems to be all set to enhance the quality of Medical Devices and Radiation-emitting products in order to ensure the patient safety. Emphasizing the same, Regulatory science at CDRH has released […]


Final Safety Rule for Antibacterial Soaps

The Final Safety Rule for Antibacterial Soaps – What manufacturers need to know?

Cosmetics, Regulatory Affairs, Upcoming Mandates

In a recent announcement, the Food and Drug Administration (FDA) has established that the antiseptic wash products with certain (19 in number) active ingredients can no longer be marketed. The final rule has seen the light with manufacturers failed to submit the data related to safety and effectiveness of those ingredients as asked in 2013. […]


Cosmetic Notification System in Malaysia

Cosmetic Notification System in Malaysia: A Gateway of Opportunities for Cosmetic Companies

Cosmetics, Regulatory Affairs

The cosmetic notification system in Malaysia has been active for quite some time now. It has given cosmetic manufacturing companies from all over the world a fair opportunity to have their products distributed in the emerging market of Malaysia. Having said that, our question is, have you notified your products in the market? If not, […]


Health Canada eyes Plain Language Labeling

Health Canada eyes Plain Language Labeling for Safe Drug Labels

Home

In a recent study in Canada, it was observed, “1 in 9 emergency cases were related to drug adverse events, and as many as 68% of those were preventable”. Prevention is better than cure. Having learnt that, the first and foremost task for the companies is to look at the ways that prevent the adverse […]


Class II Device UDI Compliance: The challenges and the ultimate solution

Freyr IDENTITY, Regulatory Operations

September 24th 2016; with the deadline, just a month away for Class II device Unique Device Identifier (UDI) compliance, it is our assumption, if not for sure, that all medical device manufacturers are well equipped with a comprehensive Regulatory roadmap. Besides having a firm grip over governance pre-requisites, manufacturers are expected to be audit ready […]


New Labeling Requirements

New Labeling Requirements – The TGA way

Labeling, Regulatory Operations, Upcoming Mandates

What does it mean for Australian Medicine Labels? In a competitive world of life sciences, releasing a medicine (innovator/reference/generic) means the first step towards success for organizations. Having so much of significance inhered in, organizations must take care of the medicinal information they ought to provide through labels. The information provided on labels should not […]


GPvP compliance reports

MHRA no longer wants GPvP compliance reports to be submitted

Upcoming Mandates

Will it be a sigh of relief for drug makers? In a recent announcement pertaining to the Good Pharmacovigilance Practice (GPvP), the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA) has updated that it no longer wants GPvP compliance reports to be submitted by organizations. With the update expected to drastically bring down the […]


Life Sciences organizations staffing balance

Should Life Sciences organizations be game for right staffing balance?

Ever evolving Regulatory landscape, healthcare system reforms, and on-going technological advancements: with these factors influencing regulatory procedures at the most, the biggest task for life sciences organizations is to reduce the operational costs while managing the procedural efficiency for end-to-end compliance. The involved costs, per say, could be of the Regulatory workforce, facilities, and other […]