Category: Biopharma

Drug Regulatory Authority of Pakistan (DRAP) Establishing Regulatory Pathway for Licensing System: A Progressive Approach

March 17, 2020
Biopharma

Drug Regulatory Authority of Pakistan (DRAP) implementing revised Licensing System, to ensure that all establishments comply with the Risk Based current Good Manufacturing Practices(GMPs) requirements...

FAMHP: New Legislative Measures for Unavailable Medicines

March 5, 2020
Biopharma

This new regulation offers for extra measures to limit the unavailability of medicines. On 3 February 2020, the law of 20 December 2019 amending various legislations regarding medicines shortages was...

TGA Issues New Guidance for TGO 101 (Standard for Tablets, Capsules and Pills)

March 4, 2020
Biopharma

The new guidance helps sponsors and manufacturers of medicines understand the role of the Therapeutic Goods Order No. 101 – Standard for tablets, capsules and pills (TGO 101, the Order) in ensuring...

Brazil – General Provisions for Stability Studies of Active Pharmaceuticals and Medicines

February 26, 2020
Biopharma

ANVISA published the Resolution RDC 318/2019, which details about the criteria for carrying out stability studies of active pharmaceutical ingredients (IFAs), and of new, innovative, generic, similar,...

Regulatory Intelligence (RI) Unbolts all your Regulatory Challenges

July 12, 2019
Biopharma

Drug development has become highly complex than ever before since the globalization of the life sciences industry. Regulatory Intelligence (RI), which emerged about 15 years ago, is comparatively a...