Pharma and Biotech Latest Insights

Curated Regulatory Intelligence Augmented by AI

Medication tablets

Pharma and Biotech

Australia: Import, Advertising and Supply Compliance Priorities 2022-23
2nd August 2022

The TGA has published a list of import, advertising, and supply compliance priorities from I...

Therapeutic Goods Medical Devices

Pharma and Biotech

TGA Guidance on Application of the Therapeutic Goods Advertising Code 2021
25th July 2022

The Therapeutic Goods Advertising Code (TGAC) was amended in November 2021 by the Therapeutic Goods...

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

Pharma and Biotech

Thailand Published Draft on the Requirements of GMP Clearance Letter for Overseas Manufacturer
19th July 2022

This regulation prescribes guidelines, procedures, and conditions for issuing the GMP Clearance letter for the...

Cannabis In Bottled Pills

Pharma and Biotech

Switzerland to Loosen Restrictions on Medical Cannabis
13th July 2022

On June 22, 2022, the Switzerland government announced the amendment to the Swiss Narcotics Act,...

Medication tablets

Pharma and Biotech

Singapore HSA Updated the Guidance on Therapeutic Product Registration
8th June 2022

They revised checklists for post-approval minor variations (MIV-1 and MIV-2) with: Re-categorisation from MIV-2 Notification...

Medicine And Poison Pharma

Pharma and Biotech

Maldives Issued a Guideline on Registration of Nutraceuticals
19th April 2022

On 1 March 2022, The Maldives Food and Drug Authority (MFDA) issued a ‘Guideline on...

Cannabis In Bottled Pills

Pharma and Biotech

Australia TGA Updates Requirements for Medicinal Cannabis
14th April 2022

In March 2022, TGA published details about the reforms to Medicinal Cannabis Products in Australia,...

Medication tablets

Pharma and Biotech

Philippines FDA Informs about Marketing Authorization of Veterinary Drugs, Vaccines, Biologicals, and Medical Devices
7th April 2022

The Philippines FDA informs all establishments and stakeholders that…...

Cannabis In Bottled Pills

Pharma and Biotech

Thailand to Partially Remove Cannabis from Illegal Narcotic List in June
8th March 2022

Key Event Summary Thailand Public Health minister Anutin Charnvirakul signed a ministerial announcement, officially modified...

Medicine And Poison Pharma

Pharma and Biotech

New Version of the Australian Poisons Standard
24th February 2022

The Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP), commonly referred to as...

Have a
regulatory affairs
challenge?

Regulatory Affair Icon

"*" indicates required fields

I want to...

I want to*
Name*
This field is for validation purposes and should be left unchanged.