Yesterday we looked at the response from the authorities in India  (COVID-19 – Regulators Respond – India Focus).  Today we’ll be focusing on the Middle East and Latin America.
Many aspects of our lives have been affected by the pandemic which has seen cases and deaths around the world.
The pharmaceutical industry has by no means escaped this impact. We have experienced an increase in demand for products used to treat COVID-19 symptoms; the disruption of product supply; an impact on manufacturing, clinical trials and R&D, the curtailment of on-site inspections, problems in meeting timelines and requirements set by regulatory agencies, I could go on…
So far in this mini blog series we have looked at flexibilities from the EU, UK, USA and India regulatory authorities, the EMAMHRAFDA and CDSCO. Today we are looking at the regulatory responses from authorities in the Middle East and Latin America.
In Qatar, the PDCD will be accepting documents for submission without legalisation, from April 2020 until further notice.
From July 2020 product licences with registration numbers 13-0001 to 15-3993 will have their validity extended until December 2021.
From July 2020 the deadline for eCTD submissions has been extended from September 2020 to September 2021.
The agency is also accepting e-documents which would replace current practice of CD/DVD-ROM submissions
In Iraq, the MOH is allowing submissions electronically via email.
All countries in Latin America are accepting applications during the pandemic except Venezuela where the MOH is still not operational.