New Quality System: Pharmacopoeia plus

Self-Regulation

Prof. Dr. V.V. Pomazanov, Professor, State Humanitarian University of Technology, Moscow, Russia, allya2005@yandex.ru

Dr. V.A. Kiseleva, Dean, Faculty of Pharmacy, State Humanitarian University of Technology, Moscow Region,

Orekhovo-Zuevo, Russia

N.I. Lidyaeva, Deputy Head, Research Laboratory of Automation Management, MAI (National Research University), Moscow, Russia

Dr. E.I. Shol’, Deputy Head of Department, Economic Theory, MAI, Deputy Head of Working Group, Self-Regulation

in Industry, Council of Self-Regulation, RF CCI, Moscow, Russia

key words

pharmaceuticals, pharmacopoeia, self-regulation, guarantees, fair business

References

The  state  registration  body  —  registration  body  —  the  Institute  of  Pharmacopoeia  — is an important part of the mechanism of state regulation in the Russian pharmaceutical market.  However,  as  the  state  supervision  authority  while  issuing  the  registration certificate  for  the  product,  it  guarantees  the  consumer  a  minimum  level  of  medicines safety.  Experience  has  shown  that  market  introduction  of  the  serial  product  does not  always  correspond  to  the  reference  sample,  registered  in  the  Pharmacopoeia. We  consider  it  expedient  to  use  the  possibilities  of  self-regulating  organizations  to solve  this  problem.  In  our  opinion,  the  Pharmacopoeia  is  the  pharmaceutical  form of  certification,  solving  the  problem  of  food  safety  prevention,  while  self-regulation institute  provides  a  financial  guarantee  of  the  declared  product  quality.  When combining  Pharmacopoeia  and  self-regulatory  institutions  it  will  be  possible  to  form the country’s system ensuring market advantages of fair business.

1. Meshkovskiy A.P. O rossiiskoy farmakopee: gde stoim i kuda idem? [On the Russian pharmacopoeia: where we stand and where we go?], Farm. Vestnik, 2013, no. 33.

2. Dorofeev V.L. Obzor standartov kachestva lekarstvennykh sredstv [Review of the quality standards of medicines], Remedium, 2011, no. 3.

3. RF Federal Law of 12/04/2010 N 61-FZ On circulation of medicines (In Russia).

4. Standart OST 91.500.05.001-00 Quality Standart of Medicines. Basic position.

5. RF Federal Law of 29/06/2015 N 162–ФЗ On standardization in Russian Federation (In Russia).

6. Federal Law of 22/06/1998 N 86-FZ On medicines.

7. Bykanov N.S., Ishchenko V.A., Lidyaeva N.I., Pomazanov V.V., Shemchishin Yu.A., Shol’ E.I. Upravlenie kachestvom: ot sertifikatsii k samoregulirovaniyu [Quality Management: From Certification to Self-Regulation], Kompetentnost’, 2015, no. 6(127), pp. 38–43.