AN ISO 9001:2008 & ISO 27001:2013 CERTIFIED COMPANY
Regulatory Rules, Opinions & Thoughts
TGA-Label-Changes-Decode-the-Updates

TGA Label Changes. Decode the Updates.

Home

It’s been almost a year since we’ve reported that Therapeutic Goods Administration (TGA) is on its way to impose new labeling requirements. Been effective from 31st Aug 2016, there have been continuous developments to the proposed labeling rules emphasizing the need to be aligned with international labeling best practices and reduce medication errors. In a […]


EMA, SPOR, IDMP, and The Story Behind

EMA, SPOR, IDMP, and The Story Behind

Home

In its latest announcement, European Medicines Agency (EMA) informed the Industry Change Liaisons that it has formally approved P&SMS Iteration 1 project covering Identification of Medicinal Products (IDMP) compatible authorized Human and Veterinary Products and Substances Management Services. This is in line with reinforcing the strategic importance of SPOR programme and implementation of a high-quality […]


EU MDR – Prepare for 2020 DL

EU MDR – Prepare for 2020 DL

Home

The regulations of the medical device industry in Europe may have remained relatively unchanged since the 1990s but recent upheavals such as the breast implant crisis and hip replacements resulted in immediate Regulatory reforms. With the EU’s new Medical Devices Regulations (MDR) formally published in May 2017, medical device companies now have three years to […]


UDI-System-FDA-Extends-Compliance-Dates-for-Class-I-Unclassified-Devices

UDI System: FDA Extends Compliance Dates for Class I & Unclassified Devices

Home

Ever since the FDA rolled out UDI rule, it has faced major hiccups down the road. Increasing concerns of medical device companies over deadlines is one among them. In a recent announcement, FDA yet again informed the compliance dates for certain Class I and Unclassified medical devices have been further extended. These set of devices […]


Regulatory-Best-Practices-A-Key-for-Faster-Drug-Approvals!

Regulatory Best Practices: A Key for Faster Drug Approvals!

Home

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. […]


Is Automation a Key Factor to Reduce Non-Compliance?

Is Automation a Key Factor to Reduce Non-Compliance?

Regulatory Affairs

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 […]


eCTD in Limelight: Should HC Electronic Submissions be your Next Focus?

eCTD in Limelight: Should HC Electronic Submissions be your Next Focus?

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 […]


Turkey Pharma Packaging Industry set for New Regulations

Turkey Pharma Packaging Industry set for New Regulations

Upcoming Mandates

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. The […]


EU to strengthen Medical Device regulations

EU to strengthen Medical Device regulations

Regulatory Affairs, Upcoming Mandates

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. With the growing concerns about the weaknesses […]