As the year-end is drawing nearby, it’s time to retrospect on all the Regulatory actions that the Pharma industry stood by to fall in compliance with Health Authority mandates. It is worthwhile to reflect upon the influential industry trends, HA guidance documents and major industry challenges that we’ve been covering in the last 12 months.
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.
- December 15, 2016 Regulatory Artwork Services, Regulatory Labeling, Health Authority Updates
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?
- November 30, 2016 Publishing & Submissions, Health Authority Updates
Are you planning for clinical or non-clinical studies post December 17, 2016? If yes, we suggest you take a look at Food and Drug Administration’s (FDA’s) study Data standards applicable for certain types of submissions to CDER and CBER.
- November 23, 2016 Publishing & Submissions, Health Authority Updates
In the October released guidance, Medicines Control Council (MCC) has given clarity for manufacturers who are willing to submit applications for medicine registrations in electronic common technical document (eCTD) format. The guidance mainly emphasized the implementation timelines of South African Module 1 eCTD Specification…
- November 17, 2016 Regulatory Artwork Services, Regulatory Labeling, Health Authority Updates
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.
- November 15, 2016 Pharmaceuticals, Publishing & Submissions, Health Authority Updates
When it comes to dossier submissions for medicine registrations, each country has its own Regulatory data requirements which should be submitted in set formats and templates. Likewise, dossier submissions towards South African market has specific format to be considered. Regulating complementary medicines in South Africa post June 2016 requires dossier submissions in ZA CTD (South Africa Common Technical Document) format…
- November 3, 2016 Regulatory Labeling, Freyr Announcements
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.
- October 27, 2016 Pharmaceuticals, Health Authority Updates
Do you remember? A couple of days back we discussed the Food and Drug Administration’s (FDA) final safety rule for antibacterial soaps. Following the US FDA’s call for the ban on specific ingredients, Japan turns the first implementation force in APAC announcing that they have implemented the ingredient ban already.
- October 18, 2016 Pharmaceuticals, Regulatory Intelligence, Regulatory Labeling, Regulatory Consulting
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.