Why eCTD (electronic Common Technical Document) should be implemented in Egypt

eCTD could enable Egypt companies to quickly finish locally and use the same system in the same language to register drugs globally.

By Dr. Maher Ashem, President of Misr Company for Information Dissemination

The pharmaceutical industry is considered one of the strategic industries in Egypt for many decades. Neighboring countries relied almost exclusively on Egyptian medicine, especially since doctors in these countries and pharmacists are also Egyptian and have full knowledge and knowledge of the medicines manufactured by Egypt.

The importance of this strategic industry has increased by increasing the population. Egypt has also become a drug-consuming market attracting international companies and inspiring national companies that have grown and become popular not only in Egypt, but in many other countries as well.

The pharmaceutical industry is one of the sectors that has grown significantly in the past 10 years, with the pharmaceutical market increasing from $ 2.8 billion in 2011 to $ 5.3 billion in 2020, according to the Ministry of Health report.

The volume of pharmaceutical trade is 70 billion pounds. We have 154 factories, all of which are subject to the new manufacturing rules. These include: 9 multinational factories, 22 international offices representing 61% of the pharmaceutical market, and 1200 companies that manufacture 40% of the pharmaceutical market. The volume of investment in the pharmaceutical sector reached 130 billion pounds.

More than half of Egypt's pharmaceutical exports are destined for Yemen, 16%, Saudi Arabia 11%, Iraq 11%, Sudan 11% and Kazakhstan 6.8%.

Exports and markets that use Egyptian medicine can be increased significantly in the Middle East and Africa, but we must first be able to communicate with the regulators in those countries in the same language as it is impossible to export to any country without the approval of the drug control authority in that country; Which requires and requires the completion of a set of tests and tests and obtain certified certificates from recognized official bodies and laboratories for the results of those tests, then these certificates are submitted to the regulatory authorities to obtain approvals for export.

The drug is also required to be registered in the country of origin.

Most global regulators use an electronic system to organize files and certificates for drug registration in a semi-standardized manner, as if they speak a single language that their spokespeople can easily understand with that group.

This system is called the Electronic Common Technical Documentation (ECTD) Electronic Document Management System.

The GCC implemented this system in October 2016, for example. Egypt is still using traditional methods to adopt any new drugs that enter the Egyptian market, which results in the following: First: prolonging the period of approval of the drug, which may reach more than 36 months compared to 12 months maximum in the GCC.

Secondly, this method can not communicate with the ECTD used in other countries, which weakens the chances of export and it is difficult for the companies wishing to do so as they are forced to register locally first in the traditional way and then wait until approval and registration in other countries electronically using the common system.

Based on the above, it is no longer a luxury for the Medical Registration Authority of the Ministry of Health to adopt the electronic medical registration system not only to reduce the time wasted waiting for local approvals but to enable local companies to quickly finish locally and use the same system in the same language to register drugs globally, Drug exports and growth may ease the pressure on our national companies limited between the high cost of components used in the pharmaceutical industry on the one hand and the forced pricing imposed by the Ministry of Health related to the income of the citizen, who suffers terribly from the effects of inflation in terms of For another.

The fact is that I do not find any logical reason why these systems should not be adopted immediately because their small cost is not comparable to the actual value of wasted time and missed opportunities to export Egyptian medicine to the Arab, African and global market.

Original article in Arabic


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