Throwback 2016
Regulatory Guidelines for the Pharma Industry, so far in ‘16
In an ever changing world of Life Sciences regulations, the Pharma industry has seen many new mandatory requirements from the health authorities worldwide.
In an ever changing world of Life Sciences regulations, the Pharma industry has seen many new mandatory requirements from the health authorities worldwide.
In an ever changing Regulatory environment, health authorities around the world mandate drug companies with various drug labeling formats and standards. To comply with those time-critical labeling mandates, organizations find it challenging to create, track and manage various aspects of drug labeling lifecycle.
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 a set of priorities for FY 2017 stressing more on modernization availing Big Data and real-world evidence.
What is Regulatory Science?
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 hidden operational burdens.
Is it the time to be alert for drug and medical device manufacturers associated with the European Union (EU) and the United Kingdom (UK)? As Britain voted to leave the EU, the situation seems to be uncertain for drug/pharmaceutical companies to plan ahead with the regulatory processes, at least for a while into the future.
IDMP has continued to be a hot topic in the pharma regulatory industry lately. It was expected that, in less than a month, EMA (European Medicines Agency) would want companies to start utilizing the defined terminologies to be submitted from July 1st2016. However, this has been further delayed according to the other industry sources. The methodologies followed by companies decide the success or failure of the implementation.
Regulatory functions such as submission and publishing, regulatory intelligence, labeling, etc. are intricate areas of the regulatory spectrum that are ever evolving. There is no doubt to the fact that some real time challenges are involved in submission processes especially now when the world is shifting from paper to electronic submissions. For pharmaceutical and life sciences companies to be able to smoothly distribute their product line in different geographies, huge volumes of data needs to be maintained.
Draw a finite line
Are you geared up with blocked timelines and strategies for upcoming drug / cosmetic Regulatory mandate? Before deciding on your next task, recheck on the category of your product to be marketed. Is it a drug or a cosmetic? Draw a finite line and understand corresponding Regulatory implications and laws to ensure your marketing efforts won’t go in vain.
Regulatory being such a vast field of operations, often tend to create confusion for what means what. One of the most dominant services of regulatory consulting that often arrives with misapprehensions is Regulatory Intelligence (RI). Regulatory Intelligence allows the regulatory professionals to determine the requirements for global clinical trials, compliance procedures, manufacturing requirements, advice personnel, answer strategic regulatory questions and develop a global marketing application.
Regulatory intelligence is an integral part to exploit effectiveness and guidance for the regulatory professional, and is at the heart of every well-informed regulatory decision.
Regulatory intelligence is an essential aspect to succeed in the regulatory landscape. Regulatory data must be harnessed and turned into actionable information as regulatory documents are readily available online and the right analysis, can deliver a wealth of insight
Regulatory Data: Potential Uses