As it has been known, for medicines, EMEA require certain documents (including the Summary of Product Characteristics (SmPC), the Patient Information Leaflet (PIL), and labels) which should be submitted in English as a first draft for necessary approvals. If there are any changes required in the draft version, they should be executed and resubmitted in the English draft.
- January 23, 2018 Regulatory Labeling
- January 17, 2018 Consumer Healthcare, Health Authority Updates
About a year after issuing the final rule for antibacterial soaps, where it has banned 19 ingredients, the US Food and Drug Administration (FDA) has come out with an announcement on similar lines.
The year 2017 was an eventful year for the Regulatory space, with several major happenings taking place across various industries such as: Pharmaceuticals, Biologics, Cosmetics, Medical Devices (MD) etc. While the MD industry witnessed the strengthening of MD regulations across the EU, the cosmetics industry saw advancements in the form of improved guidelines for cosmetic product safety.
- December 27, 2017 Publishing & Submissions
We hope you have taken necessary inputs on Health Canada (HC) eCTD format and its content structure from our previous write up.
- December 7, 2017 Publishing & Submissions
The health authority of Canadian landscape, Health Canada (HC) has revised the submission requirements and mandated submissions to be in electronic format for certain filings post January 1st, 2018.
- November 29, 2017 Medical Devices
Are you deciding on when to submit a 510(k) for a change to an existing device? As we have reported earlier, the US Food and Drug Administration (FDA) has finalized the guidelines on changes in medical devices that would need a 510(K) submission.
The guidance is expected to aid manufacturers of:
- November 24, 2017 Regulatory Artwork Services
Artwork designing and packaging is often treated as an outsourced business segment given the fact that not all the technical team members from the manufacturer’s side will have that creative outlook or the promotional perspective on the subject. Even if they possess the creative knowledge, due to lack of dedicated design suites they prefer it to be outsourced.
- November 16, 2017 Regulatory Software & Services
As popularly known, IDMP (Identification of Medicinal Products) can be defined as a set of common global standards and technical specifications of data elements, formats and terminologies that enable unique identification and exchange of medicinal information.
- November 9, 2017 Compliance, Audit and Validation
Between 10/1/2015 and 9/30/2016, the United States Food and Drug Administration (USFDA) through its system has issued almost 3905 483s to Biologics (84), Medical Devices (934), Drugs (691), and Food (2196) manufacturers. The number shows that there is significant rise in manufacturing violations when the health agency inspected respective facilities.
- November 7, 2017 Regulatory Labeling, Health Authority Updates
Do you know? Excipients which are used in drugs, thought to be inactive, but in some circumstances, they may lead to severe reactions. To safeguard patients from such adversities, the European Medicines Agency (EMA) has updated its annex to the European Commission’s guideline on the labeling of five new excipients.