When it comes to measuring the success of a new medicine, the amount of time taken to complete the entire approval process becomes a crucial factor. With the growing need to speed up the market launch and address the unmet needs of patients, major global health authorities have in turn accelerated the drug approval processes.
- June 7, 2017 Pharmaceuticals, Regulatory Intelligence
- May 30, 2017 Compliance, Audit and Validation
The term “regulatory compliance” takes on different definitions depending on the industry it is being applied to. But from an elevated level, compliance is all about incorporating requisite standards that conform to certain requirements and in relation to Regulatory it is nothing but a set of regulations that any given organization must follow to meet specific requirements.
- May 25, 2017 Publishing & Submissions, Health Authority Updates
With the FDA concluded its mandatory first phase electronic submissions deadline, first question drug manufacturers could ask themselves is what’s next in line? Where else they can submit their data and which format they should get adopted to? With their target focused on global markets, we suggest to take one-at-a-time approach. With that said, the next market they should focus for their data submissions is Health Canada…
- May 24, 2017 Pharmaceuticals, Regulatory Labeling, Health Authority Updates
Codeine medicines seems to have attracted all the attention right now. Not for the ways they are to be used, but for the ways they need to be labelled and advertised. To protect children from serious risks, two top most health authorities, the US Food and Drug Administration (USFDA) and the Therapeutics Good Administration (TGA) have rolled out label and advertisement changes.
- May 10, 2017 Regulatory Artwork Services, Health Authority Updates
Keeping at par with industry trends and following the European Union directives, Turkey has recently introduced a new regulation on packaging, inserts and tracking of pharmaceuticals. On April 25th, 2017, the Turkish Ministry of Health published the Regulation on Packaging Information, Inserts and Tracking of Medicinal Products for Human Use in its Official Gazette.
- May 4, 2017 Medical Devices, Health Authority Updates
With over 5,00,000 types of Medical Devices (MDs) and in-vitro diagnostics (IVDs) existing, the European MD and IVD market stands as a major economic player. On the other side, recent scandals pertaining to certain classes of medical devices exposed the frailties of medical device regulations in the region.
- May 3, 2017 Pharmaceuticals, Freyr Announcements, Regulatory Consulting
The upsurge of economic and industrial developments across the Middle East and North Africa has established the MENA region as a dynamic life sciences and healthcare market. As per reports, consistently growing affluence in the Gulf Cooperation Council (GCC) countries has led to many lifestyle changes resulting in steep rise in total healthcare expenditures.
- April 19, 2017 Health Authority Updates
As said and done for many times till now, the United Sates Food and Drug Administration (USFDA) has set a compliance deadline for eCTD (electronic common technical document) submissions. The deadline for the first phase is on 5th May 2017 and for the second phase, it is on 5th May 2018. What’s there to reconsider now?
It is drug manufacturers’ responsibility to ensure the drug/device is developed in accordance with compliance and is also used in safe and secured way. When it comes to hazardous drugs (HD), they are obliged to inform the healthcare facilities about the ways to handle them.
- April 13, 2017 Regulatory Affairs, Publishing & Submissions
Ever since the Hatch-Waxman Act came into being, the generic drugs have saved billions for both patients and healthcare systems alike and accounted for 88% of the prescription drugs sale in the United States alone.