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Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling

Pharma and Biotech

MFDS Proposed Partial Revision of Regulations on the Safety of Pharmaceuticals
25th July 2023

Korea Ministry of Food and Drug Safety (MFDS) proposed a partial revision to Regulations on...

Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling

Pharma and Biotech

US FDA Provides Recommendations on the Statutory Prohibition on Wholesaling for Certain Compounded Drugs
10th July 2023

According to FDA, this draft guidance describes the FDA’s interpretation of, and policies concerning, the...

Cannabis In Bottled Pills

Pharma and Biotech

Thailand Proposes Standards Regarding the Supervision of Herbal Products Containing Cannabis or Hemp
10th May 2023

The Thailand Ministry of Public Health proposes draft standards regarding the Supervision of Herbal Products...

Medicine And Poison Pharma

Pharma and Biotech

Thailand Published the Criteria, Methods and Conditions of Drug Research Studies
4th April 2023

The Thailand Ministry of Public Health published the benefits of promoting, supporting, and developing effective...

Medicine And Poison Pharma

Pharma and Biotech

TGA Introduced Changes Applying to Evaluation of New Substances for Listed Medicines
21st March 2023

The TGA has introduced changes regarding the evaluation of new ingredients to be used in...

Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling

Pharma and Biotech

Taiwan FDA published Guidelines for the Implementation of Drug Epidemiological Safety Research Using Electronic Health Care Data
7th February 2023

Real-world evidence is the latest international clinical application trend, which can be used to improve...

Herbal Products Thailand Published Draft On The Requirements Of Gmp Clearance Letter For Overseas Manufacturer

Pharma and Biotech

Thai FDA Issued Criteria, Methods and Conditions for Sampling of Herbal Products
2nd February 2023

The Thai Food and Drug Administration (TFDA) Issued Criteria, methods, and conditions for the sampling...

Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling

Pharma and Biotech

EU Recommendations to Facilitate the Conduct of Decentralized Clinical Trials (DCTs)
1st February 2023

The European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency...

Herbal Products Thailand Published Draft On The Requirements Of Gmp Clearance Letter For Overseas Manufacturer

Pharma and Biotech

Thailand Issued a Draft Notification on the Names of Substances Prohibited as Ingredients in Herbal Products
3rd January 2023

There are 3 lists of substances (plants, animals or parts of plants or animals), prohibited...

Amendment To The Clinical Trials Regulation (ctr) On Investigational Medicinal Products (imps) Labelling

Pharma and Biotech

EU: Amendment to the Clinical Trials Regulation (CTR) on Investigational Medicinal Products (IMPs) Labelling
13th December 2022

The European Commission (EC) revised the current labelling requirements provided in the Clinical Trials Regulation...

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