[e-drug] Africa prefers WHO prequalification over FDA registration (2)

["BONFACE FUNDAFUNDA" <bcfunda@hotmail.com>]

E-DRUG: Africa prefers WHO prequalification over FDA registration (2)
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Dear all,

I think this is typical of the 'politics' in development sector that is overshadowing  reason.  I  agree with James Makumbi's (Uganda NDA) comment that what we are seeing is a problem of lack of interaction between key players (good to see that this is resolved or resolvable). All of us involved in regulatory issues understand the need to protect public safety through such national regulations. WHO offers a  unique  service to those countries that do not have the means to conduct  strict assessment  of  manufacturing and product quality. In that respect, both WHO and FDA are singing the same song.

However, unnecessary controversy (quoting Paul Zeitz) has  been generated,  and possibly by those who have little understanding of the purpose and intent of the regulatory process. Paper registration of a drug does  equate  a public safety measure. All national regulatory agencies know that fact. If one regulatory measure takes 4 months and another 12 months, we should stop and establish (a) why it takes that long,  (b) what is the process being followed (c), etc; there may be justifiable reasons at play, and not an unwillingness to make products available.

As we can  see from submissions in this article, different countries have their  own  framework for product registration; some have great resources to conduct  stringent regulatory service. But those who do not have such stringent measures, they might  be better served by following WHO or indeed FDA recommendations, and those of other recognised regulatory authorities.

This is a tough business to be in, specifically the regulation of generic products, as we've seen recently with generic ARVs.  Given the many areas that need to be assessed / investigated as part of the regulatory process, it needs cool heads, calm minds and resources to do this job. But above all, we need to understand the purpose of all of this activity: taking care of public health and safety.  Therefore, to suggest that a regulatory process creates unnecessary delay and therefore puts people at risk, is in itself a dangerous position to hold in respect to public safety.

 Regards,
 Bonnie Bonface Fundafunda PhD, MBA, B.Pharm(Hon)
 Birkevej 32, Tranegilde Strand,
 2635 Ishoj,
 Denmark
"BONFACE FUNDAFUNDA" <bcfunda@hotmail.com>