A Good Manufacturing Practice (GMP) inspection of Micro Labs Ltd., Kumbalgodu (ML08) was carried out by the World Health Organization 27-31 August 2018.
The following products were added:
The 6th NTD EOI adds fexinidazole for Human African trypanosomiasis (HAT) and clarifies the scabies indication for ivermectin.
The following products were deleted:
DEADLINE EXTENDED TO 15 DECEMBER 2018
WHO today launches a pilot project for prequalifying biotherapeutic medicines, a step towards making some of the most expensive treatments for cancer more widely available in low- and middle-income
On 07 April 2017, WHO issued a position paper on the import alert placed on, Qinhuangdao Zizhu Pharmaceutical (QZP) by the United States Food and Drug Administration (USFDA) on 8 March 2017.
Pre-submission meetings provide an opportunity for advice and guidance prior to submission of a medicines dossier, as well as an opportunity for the applicant to meet the PQT medicines (PQTm) asses
The previous exception to allow 3 months stability data (at time of submission) for RH and 2nd line TB products was made, as an interim measure, to encourage the submission of poorly-represented pr