When the COVID-19 pandemic was first recognized as a global health crisis in 2020, global Health Authorities (HAs) took innovative steps to deal with it in the best possible manner. Likewise, pharmaceutical companies came up with several vaccines/medicinal products for the benefit of the public. However, registering the products turned out to be quite challenging. To simplify the registration while upkeeping their safety, quality, and efficacy, HAs granted Emergency Use Authorizations (EUAs) to a few vaccines and relevant products.

Do you know? One can save up to a million in the coming three (03) years by introducing Computer Software Assurance (CSA) in place of the existing Computer system validation (CSV) model!

Over the years, pharmaceutical organizations have incorporated CSV, a risk-based validation approach to ensure computer operating systems are at par with Regulatory requirements.

FSSAI published a major update on the Front Pack of Labelling (FOPL) on 22nd February 2022 after a meeting with the stakeholders, to decide the remaining issues related to ‘Front of Pack Labelling’ under the Chairmanship of CEO, FSSAI. The FSSAI commenced the meeting with a presentation on the development journey of FOPL in India and the decisions taken in the last meetings.

Below are the highlights of the update:

Brazil is the largest cosmetic market in the Latin American region. Increasing consumer awareness and a rising disposable income ensure steady market growth. Major international cosmetic brands also have a presence in this attractive market.

As a cosmetics manufacturer, it is necessary to stay informed about the changing regulations across the globe.  A failure to adhere to region-specific regulations often results in disciplinary action from the concerned Authorities.

With the advent of digitization, many global organizations, especially in life sciences and med-tech industries, have randomly shifted their data from paper to digital forms. Thanks to the stringent regulations, like US FDA’s 21 CFR Part 11 (21 CFR 11) regulation, the digitalized data forms are coming out to be accurate, efficient, productive, quality-oriented and reliable. The 21 CFR 11 regulation is a part of the Code of Federal Regulations, which establishes the US FDA regulations for electronic records and signatures.

We all are aware of how food and medicine are different in terms of how they individually nourish the body, but both eventually tend to mainly assist in maintaining our health. While we are trying to enhance our immunity, improve our stamina or deal with current chronic health concerns, we sometimes tend to buy unknown food and food supplements, with poor labeling, which can cause more harm than good.

The medical devices industry is considered as highly regulated. Hence, devising a right Regulatory strategy will be a potential approach and a great value-added contribution to avoid Regulatory roadblocks. Especially, medical devices manufacturers willing to launch their products in the ASEAN geographies have to walk through stringent regulations, as different markets portray different Regulatory requirements.

Clinical and nonclinical research programs demand the development of high-quality documents for timely submissions and approval of the drug product from Regulatory authorities. Medical writing plays a crucial role in drafting all the necessary documents right from drug development through submission and approval. When filing Investigational New Drug (IND)/ New Drug Applications (NDA) to the USFDA, medical writers are obliged to develop high-quality documents by collating all nonclinical, clinical and scientific data in a standard, comprehensive, and logical manner for Agency’s review.

The MDCG (Medical Device Coordination Group) has released a position paper on UDI assignment to assist the manufacturers of spectacle lenses and ready readers about the obligations under the EU Medical Device Regulations (EU MDR) 2017/745. It also has the details to be considered while assigning an UDI (Unique Device Identification) to these devices. In addition, this position paper defines the data elements for BASIC UDI and UDI-DI groupings for spectacle lenses and ready readers.

You may know that the Medical Device Coordination Group (MDCG) has released a Q&A document related to previously released guideline - MDCG 2020-4: guidance on temporary and extraordinary measures related to medical device Notified Body audits during COVID-19 quarantine orders and travel restrictions. The recent release throws further light on key considerations while adopting remote audit model by the Notified Bodies for conformity assessments.