Regulatory Blog

On 27th August 2021, Irelands Health Products Regulatory Authority (HPRA) released a new "Guide to Reporting and Initial Investigation of...

A new pathway supporting innovative approaches to the safe, timely, and efficient development of medicines to improve patient access was...

On 30th August 2021, the Center for Devices and Radiological Health released 2 new draft guidance related to Premarket, 510(k). i.e.,...

On 25th August 2021, the Oncology Center of Excellence along with the Center for Drug Evaluation and Research released new draft guidance...

The MDCG Guidance provides an overview of activities, requirements, auditing, surveillance and changes and minimum content of the...

Malaysia’s National Pharmaceutical Regulatory Agency (NPRA) released guidance on the distant assessment of good manufacturing practices...

The Gulf Health Council released a new updated version of the guidance on 12th August 2021 on “Guidance for Presenting the Labeling...

This guidance document is intended to provide a general description of FDA Export Certification to industry and foreign governments. This...

On August 20, 2021, FDA Center for Drug Evaluation and Research (CDER) published a revision to the draft guidance for industry...

Each year, TGA registers approximately 40 new prescription medicines containing new active substances. We refer to these as New Chemical...

Software-based Medical Devices are medical devices that incorporate or are software, including software as a medical device, or software...

The Philippine Food and Drug Administration (FDA) released an addendum to circular (to FDA Circular No. 2021-002) on the transition to...

The User Fee programs help the Food and Drug Administration (FDA) to fulfill its mission of protecting public health and accelerating...

On 12th August, 2021 the US Food and Drug Administration (FDA) announced the establishment of a public docket to solicit comments on...

World Health Organization (WHO) recently issued revised guidance to industry addressing good manufacturing practices (GMPs) for...

US Food and Drug Administration (FDA) on 06-July-2021, finalized guidance on “Development and Submission of Near Infrared Analytical...

USFDA on 06-July-2021, finalized guidance on the use of metastasis-free survival (MFS) as an endpoint in clinical trials for...

Swismedic released multiple Guidance documents on 1st august, 2021 and are as follows 1. Guidance document Variations and extensions HMV4...

Medical Device Coordination Group Document (MDCG) published a guidance (MDCG 2021-19) note integration providing recommendations on how...

The European Commission has confirmed that the entry into application of the Clinical Trials Regulation and hence the go-live date for...