Last week’s round-up, 02 – 06 March 2020

By Stephanie Allampalli, Tessa Fiorini-Cohen and Marthese Mifsud


Coronavirus: Drug shortage fears as India limits exports – BBC News

06 March 2020

In the wake of the coronavirus epidemic, India has limited the export of certain medicines and active pharmaceutical ingredients (APIs).

India is the world’s largest supplier of generic drugs and almost 70% of the active ingredients used in these medicines are produced in China. Due to the current epidemic, many Chinese manufacturers of APIs have reduced their output or ceased operations completely, therefore, possibly leading to drug shortages.

The export of 26 APIs and the pharmaceuticals produced from them has been restricted. These include paracetamol, some antibiotics, such as tinidazole and erythromycin, the hormone progesterone and Vitamin B12.

The Indian government has said that there are enough stocks to last for up to three months, however, industry experts have warned that as the coronavirus epidemic continues, drug shortages and an increase in the prices of the pharmaceuticals concerned can be expected.

ICH Q12 Technical and regulatory considerations for pharmaceutical product lifecycle management

05 March 2020

The final version of ICH guideline Q12 has been published.

ICH Q12 covers technical and regulatory considerations for pharmaceutical product lifecycle management. It has been in the works for quite a while and is intended to globally harmonise the management of post-approval changes to chemistry, manufacturing and controls (CMC).

However, there are some conceptual differences between ICH Q12 and the current EU legal framework, meaning that there are limitations on how fully ICH Q12 can currently be implemented within the EU. Incompatible sections are those on scientific risk-based approaches to defining established conditions and associated reporting categories (described in Chapter 3.2.3 of the new guideline) and on the product lifecycle management document (PLCM, described in Chapter 5).

Within the EU, regardless of the current text within ICH Q12, the definition of established conditions and their reporting categories must follow the requirements laid down in the current EU Variations Regulation and associated EU guidelines. The PLCM cannot currently be recognized if submitted.

FDA Issues 43 Product-Specific Guidances for Generic Drugs

04 March 2020

The FDA has issued 33 new and 10 revised draft product-specific guidances to support the development of generic drugs.

Through these draft guidance documents the FDA aims to clarify its expectations for bioequivalence studies required for certain generic products, including complex generics delivered via metered dose inhalers or sprays.

The FDA has also updated its list of planned product-specific guidances for complex generics for the year ahead.

Changes to SPC and patent law from 1 January 2021

03 March 2020

Changes are on the way for supplementary protection certificates (SPCs) and patent law within the UK, as a result of Brexit.

Authorisations from the European Medicines Agency will be converted into equivalent UK authorisations on 1st January 2021, and holders of SPCs which rely on an authorisation from the EMA may be asked to provide information on the converted UK authorisation. New applications for related pediatric extensions will follow a similar procedure to the current one, except evidence of authorisations covering the product across the EEA will no longer need to be provided. The UK is still considering the final form of legislation that will be implemented in relation to manufacturing waiver to SPCs, introduced by the EU last year.

A few specific areas of the patents process will also change. Community plant variety rights will no longer have an effect in the UK. However, these can be converted to UK rights at the end of the transition period. The UK will also no longer fall within EU’s arrangements for civil judicial cooperation.

Full details on what is changing and what is staying the same can be read here:

The Value of One: What Can We Learn from Case Studies?

02 March 2020

An increasing number of researchers are taking on a different approach to scientific research through N of 1 trials to study pain, nutrition, psychology and other very personal health issues.

This kind of research involves taking many measurements from one person over time, as opposed to taking a few measurements from a large group of people. This allows for the comparison of results of two different interventions, such as two different pain medications or two different diets, as well as placebo effects. The subject of the study may also have the power to change the approach and goal of the study to suit their own needs.

According to an N of 1 research coordinator at the University of Queensland in Brisbane these one-person studies can be as statistically and scientifically rigorous as large-scale studies. This kind of research has the potential to bring to light results which may be lost in standard large-scale studies.

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