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In January 2006, the United States Food and Drug Administration (US FDA) introduced Structured Product Labeling (SPL) format for submitting product and facility information and changes to label submissions. The shift towards the new electronic format was aimed at uniformly informing patients, physicians, pharmacists, and the agency about the label content.
On May 27, 2016, the United States Food and Drug Administration (US FDA) published the final rule for nutrition and supplement facts label in the Federal Register. The final rule ensures that the label reflects new scientific information including the link between diet and chronic diseases like obesity and heart disease.
The life sciences industry is ever-changing and evolving. It’s the same in the year 2018. A lot of mandatory changes have been made to the regulations, and a lot of guidance documents have been released pertaining to the best Regulatory practices of consumer healthcare, medical devices, pharmaceuticals, which are expected to impact the industry in a positive way.
The National Health Regulatory Agency (ANVISA) of Brazil, on 22 November 2018, published a new standard - Resolution RDC 250/2018 related to the Official Gazette of the Union. The new resolution, related to Cosmetics labeling, was passed to enhance the agility of the cosmetics sector in Brazil and reduce the cost of labeling processes to the organizations.
Be it a drug, device, cosmetic or food product, it is essential to convey the product information with respect to its usage, indications, warnings and other crucial aspects that are informative and beneficial to the end-user.
Lack of clarity on indications and uninformed usage of drugs and biological products may lead to unforeseen adversities, which might in turn affect manufacturers / sponsors through financial penalties and legal actions.
The United States Food and Drug Administration’s (USFDA’s) Pregnancy, Lactation and Labeling Rule (PLLR), which came into effect in June 2015, establishes a labeling standard for prescription drug products which can be used during maternity and lactation.
Effective communication can bridge information gaps between two different ends of a process. With so many processes involved and with a need to communicate accurate safety information to the end user, the Pharmaceutical industry must employ utmost caution when taking its products to market.
Therapeutic Goods Administration (TGA), the Australian regulatory authority has approved a new product information (PI) form on 8th November 2017. The commencement date of the new PI form was 1st January 2018, with a transition period of three years ending 31st December 2020.
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.
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