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.
Is it the clinical pharmacology section of generic drugs and biologic’s labels requiring your attention? Are you chalking out a plan to gather the related data? Then it is the time you should know about Food and Drug Administration’s (FDA’s) finalized guidance on labeling. Here’s a quick overview.
What is Clinical Pharmacology?
If the latest government figures are any witness, the United Kingdom Life Sciences industry is a thriving £60 billion market, employing 220,000 people, and any potential threat to its growth is quite understandably worrisome. So, even when BREXIT (Britain’s exit from the EU) is at least two long years away, the current atmosphere is marked with constant speculations of its long-term impact on the strategic Life Sciences industry.
Now that we have decoded various Regulatory Labeling challenges from different perspectives, is it the time you think to scout for a comprehensive Regulatory Framework? The answer would be a sure shot yes leading to search for innovative products, technologies, solutions, and services the industry is offering.
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 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 instructions and integrity of the information on the label while prescribing to patients, which further makes it unavoidable for companies to roll out their products with inaccurate labels.
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 events? Apart from standardizing the drug invention and clinical processes, perhaps the obvious way would be to inform the end user about the drug and its actual usage process in a most perceivable manner.
What does it mean for Australian Medicine Labels?
The US Food and Drug Administration (FDA) has recently released the optional final labeling rule specific to use of stand-alone symbols in order to align to the global standards for medical device and in vitro diagnostic (IVD). This is the first time that the manufacturers in the U.S. will have the liberty to implement new labels to meet the labeling norms not only in the U.S. but also in the regions except U.S.
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.