E-DRUG: RFI: Bioequivalence and generics registration (8)
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Dear all,
I fully agree with Andy's opinion about regionalising critical
services in this case. Many of us have called for this in respect to
other services, QA/QC being just one of them. However, let us also
agree that the primary purpose of a regulatory authority in respect to
medical products (drugs in this case), is to protect public health and
safety. By our actions, we need to have that fact in mind, and decide
how best we can assist this institution. It is common to find voices
that down play the role of such institutions like the national
regulatory authority (as much as other instruments of government
designed to provide effective healthcare), specially where they are
under- resourced. But if the fact of public safety underpins our
thoughts about the role of the regulatory authorities, then there may
be readiness to support those weak regulatory offices (material,
staff, salaries, etc) at country level. Alternativey, the idea to
regionalise such services may also find greater support at both
political and donor levels.
Regards,
Bonnie
Bonface Fundafunda PhD, MBA, B.Pharm(Hon)
21 Beverstone Road,
Thornton Heath,
Surrey CR7 7LL
England
bcfunda@hotmail.com
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