Regulatory Challenges In Global Clinical Trails
In the new patent era pharmaceutical companies have changed their strategy to market their products
. They are launching products in multiple markets with a single shot to capture their share. In order to get an approval for marketing of their product, regulatory bodies are insisting on clinical trials of land for the safety concerns of the people of their region and suspecting and questioning the efficacy of the product. In this situation one has to go with global thinking with local regulatory process awareness.
Initially, there are hurdles in trial design across multiple centers due to regional differences in medical practice. In this case, number of sites to be identified, number of patients to be recruited to each site, lack of homology among these sites, the duration and length of the trial to be conducted, varies for which regulatory and IRB/IEC approvals are mandatory.
In a global study, another important issue is the translation of documents into multiple languages. In fact, in India if we want to conduct a multi-center trial, we need to translate all IBs, ICFs, and Protocols into 14 languages and we need to get the approval of respective IEC's. This creates much delay in study initiation and if any adverse event reporting to regulatory body.
Another important aspect is the qualification of Investigator in respective domain and region to conduct study. There is reciprocity on qualification of investigator within EU, Canada, Australia, New Zealand, Japan, and Switzerland, even ICH E6 does not speak much about investigator qualifications. In case of Indian GCP guidelines, it says just that the investigator should be a qualified medical practitioner and registered with medical society of India. In this way there are multiple eligibility norms to be an investigator in conducting a global trial.
In relation to ICF and patient recruitment, there are regional differences, language and cultural barriers to recruit patients for the study. Subjects need to be educated about the pros and cons of the study in different sites and different languages. Sometimes if the study is to be conducted in remote zones, vernacular form of ICF needs to be prepared for smooth conduct of study.
Staff training on GCP compliance and safety reporting is another important aspect of global study. Nave staff needs much intensive training on GCP and country specific regulations and safety reporting. All training contents need to be translated to respective languages and should be geographic and specific in nature. Unexpected and serious adverse events to the
Regulatory authorities must be reported in each participating country, regardless of the country of origin, is another important task in global study.
In case of clinical supply for the initiation of study, we should follow the specific labeling requirements of the country of origin. Certified translations, types of information for labeling, outside packaging with chemical name, Investigational Use statement, name/address of Sponsor (in country), manufacturing lot number, batch number, storage conditions, expiration date, protocol name, dosage form, number of units, route of administration, subject number, directions for use, Keep out of reach of children and For Investigational Use. All these details should be translated as per regulatory requirements of the country and devoid of this may lead to failure of getting the product imported.
The product needs to undergo analytical process before proceeding to study. The fact that this is yet to be harmonized by different pharmacopoeia standards is another technical barrier. For example, drug products originating in US must be re-analyzed in EU and vouched for by Qualified Person as per EU clinical directive. EMEA does not recognize US GMP data, as EU has separate GMP standards. But there is light at the end in this process recently; both USFDA and EMEA came to agreement to respect each others processes, in order to simplify the clinical trial approval process for pharmaceutical companies wish to conduct study.
The last and most important factor is the Regulatory approval timelines, which are different in various countries where the study has to be conducted. This may lead to a delay in product commercialization. Hence one needs to think strategically and act locally as per the norms in force to get an approval from different regulatory bodies for smooth conduct of the study.
by: Ragalahari
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