Luanda - A Medicines Registration System (SIREMA) was launched today, Thursday, in Luanda, by the Ministry of Health (MINSA), with the aim of automating and accelerating the internal and external processes of the Medicines and Health Technology Regulatory Agency (ARMED).
The digital platform - SIREMA - will allow users to register their entities and digitally submit requests for authorization to introduce products into the Angolan market.
In addition to making the registration and request submission process more dynamic, SIREMA also reduces the time spent analyzing and approving documents.
At the launch, the Secretary of State for Public Health, Pinto de Sousa, said that SIREMA, whose implementation will allow the automation and acceleration of processes, has automatic adjustment features to different resolutions and device screen types mobile devices (cell phones and tablets), which can be used across a wide range of devices.
He added that MINSA, through order no. 11 / ARMED / MINSA / 2022, began the expedited process of registering medicines, for public health reasons, prioritizing the therapeutic groups of antimalarials, anti-tuberculosis and anti-retrovirals.
The secretary referred that the registration of medicines constitutes a set of technical-administrative procedures for evaluating the medicine for its official introduction into the national market.
“We hope that with SIREMA, the registration of the three groups of priority pharmacotherapeutic medicines will be speeded up and consequently we will have an inventory of medicines in circulation in the country”, he reinforced.
He added that the Ministry of Health regulates, guides and supervises the practice of traditional medicine and complements it to effectively guarantee medical and medicinal assistance to everyone.
He recognized that there is still a lot to be done to improve the pharmaceutical sector, but MINSA has worked diligently to develop and update the regulations for this sector, in line with international standards, namely those of the WHO, ICH, SADC and AMA. .
According to the World Health Organization (WHO), 30% of medicines sold in the markets of developing countries are counterfeit, of low or dubious quality.
In this sense, it advises that each country implement a Medicines Registration Process (or Marketing Authorization process) to ensure their safety, effectiveness and quality.
Pinto de Sousa called on importers to adhere to the medicines registration process, in order to improve the business environment in the sector and thus reduce unfair competition.
In turn, the general director of ARMED, Pombal Gonga, stressed that this moment represents a significant milestone in improving efficiency and transparency in the medicine registration process in the country.
He highlighted that this system also reflects the Angolan Executive's commitment to implementing digital means in public administration, aiming to simplify and reduce the duration of procedures, promoting the speed of processes, ensuring greater safety and quality of medicines available on the market.
For the US diplomatic representative, Joana do Rosário, the launch of SIREMA is in perfect harmony with the strategy of the Governments of Angola and the United States for innovation and technology.
He firmly believes that digital transformation is essential for the progress and prosperity of all nations and stated that the American Government supports and is engaged with initiatives that use technology to solve problems, improve efficiency and increase transparency in government and business processes.
For this reason, USAID, through its Global Supply Chain Management, Procurement and Logistics Management program, has been working with partners, ARMED, Ministry of Health's Office of Information and Institutional Communication Technologies, Institute for Administrative Modernization, as well as the Data Protection Agency - to improve this digital platform.
“The United States Government's strategy in Angola for the sector is to support the development of an integrated and sustainable health system, in addition to strengthening the workforce, enabling it to provide quality health services to all Angolans”, he added. EVC/PA/DOJ