Hi! I hope that you are doing great. These days have been so active and dynamic, don’t you agree? A lot of things have been going on all around the world in so many ways, affecting the economy as well as society and nature.
There is a solid fact about economy in the world that has become more and more important, which is the “Emerging Markets”. According to Forbes, a very reputable magazine “The emerging markets are fast becoming the driver of global growth.” That is so true!
Then, which countries are included in Emerging Markets?
Alphabetically, the most known are Argentina, Brazil, Chile, China, Colombia, Dominican Republic, Ecuador, Egypt, India, Indonesia, Jordan, Korea, Kenya, Lebanon, Malaysia, Mexico,Moldova, Morocco, Pakistan, Peru, Philippines, Russia, Senegal, South Africa, Thailand, Tunisia, Turkey, Ukraine, Uruguay, Venezuela, Vietnam and there are many more. This fact has an impact on pharmaceutical industry just like it has on any other industries.
Many pharmaceutical companies are working on being active in those markets. So Regulatory Affairs has a vital effect here. There are many countries and many regulations! Each country requires different things in addition to common known ones. There are some general keys to keep in mind in order to be successful in RA there. Those keys are:
- It is beneficial to have local contacts and experts in order to be in touch with the health authority and follow the cycle of the registration process.
- They are all in different climatic zones. So, the stability studies have different conditions to be carried out. Be aware of that and do your paper work and lab work accordingly. You can check ICH and WHO guidelines on http://www.ich.org/products/guidelines/quality/article/quality-guidelines.html
- There are different requirements for bioequivalence studies and clinical studies. Some countries require extra studies.
- Some countries require extra paper work and studies for pharmaceutical development part especially in generics. It should be discussed with your colleagues, there.
- Manufacturing part is asked to be given in more details than usual (CTD version) in some markets. (For example some specific items about packaging stage are asked)
- In addition to point 5 above, some extra information is asked in Process Validation about the manufacturing steps and the batches.
- Extra administrative documents may be asked in some countries. For example Halal certificate is asked in some countries like Malaysia.
- Extra requirements are asked for SPC and PIL preparations as well as mock-up studies in some countries.
Well, these are the basic ones that come to my mind. Do you have any other items to add? Please leave your comments below and feel free to share on social media.
Thank you & Have a wonderful week!
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