Have a
regulatory affairs
challenge?
Pharma and Biotech Latest Insights
Curated Regulatory Intelligence Augmented by AI
Pharma and Biotech
ICH Solicits Public Opinions on Draft Guideline for Pharmacoepidemiology St…
On July 12, 2024, the CDE (Center for Drug Evaluation in China) announced that the...
Read more
Pharma and Biotech
China’s NMPA Seeks Public Feedback on New Draft to Expedite Approval …
On June 25, 2024, the National Medical Products Administration (NMPA) released a draft for public...
Read more
Pharma and Biotech
TGA Updates Permitted Ingredient List for Listed Medicines, June 2024
On June 06, 2024, the Therapeutic Goods Administration (TGA) published an update to the list...
Read more
Pharma and Biotech
NMPA Announces OTC Switch for Naftifine Ketoconazole Cream and Metronidazol…
On July 5, 2024, the National Medical Products Administration (NMPA) announced the reclassification of Naftifine...
Read more
Pharma and Biotech
EMA Recommends Approval of the First Vaccine to Protect Adults Against Chik…
On May 31, 2024, the European Medicines Agency (EMA) announced its recommendation for the approval...
Read more
Pharma and Biotech
Thailand: Updated Dosage Limits for Drugs Containing Fat-Soluble Vitamins
The Ministry of Public Health in Thailand has unveiled a draft notification outlining updated dosage...
Read more
Pharma and Biotech
Proposed changes to the Pharmaceutical Advertising Advisory Board (PAAB) Co…
Health Canada is currently scrutinizing a significant revamp of pharmaceutical advertising standards proposed by the...
Read more
Pharma and Biotech
TGA Seeks Input: Adoption of International Scientific Guidelines
The Therapeutic Goods Administration (TGA) Australia is actively seeking public input on the adoption of...
Read more
Pharma and Biotech
Thai FDA’s Proposed Draft Notification: Annual Safety Reports for Con…
Thai FDA proposes a draft Notification mandating annual safety reports for terminated or completed clinical...
Read more
Pharma and Biotech
US FDA Eases Informed Consent for Minimal Risk Clinical Trials
FDA Implements 21st Century Cures Act: Effective 30 days post-publication, ensuring rights and safety of...
Read more