Top 10 Pharma – products in the pipeline

Did you know that you can consult which new innovations are in the pipelines of the top 10 pharma companies directly from their websites?

Have a look!

1- Johnson&Johnson

2- Pfizer

3- Novartis

4- Sanofi

5- Merck&Co

6- GlaxoSmithKline

7- Abbott

8- Roche

9- Bayer

10- AstraZeneca

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Anvisa Approves Track and Trace System.

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List of FDA Advisory Committees

The FDA Advisory Committees for drugs and other healthcare products receive requests for technical and clinical evaluation of new drugs by the U.S. Food and Drug Administration. The committees, consisting of members from academic and clinical settings, the general public, and the pharmaceutical industry, make non-binding recommendations to the relevant divisions of the FDA about the advisability of approving new products.

Blood, Vaccines and other Biologics

  • Allergenic Products Advisory Committee
  • Blood Products Advisory Committee
  • Cellular, Tissue and Gene Therapies Advisory Committee
  • Transmissible Spongiform Encephalopathies Advisory Committee
  • Vaccines and Related Biological Products Advisory Committee

Drugs

  • Anesthetic and Analgesic Drug Products Advisory Committee
  • Anti-Infective Drugs Advisory Committee
  • Antiviral Drugs Advisory Committee
  • Arthritis Advisory Committee
  • Cardiovascular and Renal Drugs Advisory Committee
  • Dermatologic and Ophthalmic Drugs Advisory Committee
  • Drug Safety and Risk Management Advisory Committee
  • Endocrinologic and Metabolic Drugs Advisory Committee
  • Gastrointestinal Drugs Advisory Committee
  • Medical Imaging Drugs Advisory Committee
  • Nonprescription Drugs Advisory Committee
  • Oncologic Drugs Advisory Committee
  • Peripheral and Central Nervous System Drugs Advisory Committee
  • Pharmaceutical Science and Clinical Pharmacology Advisory Committee
  • Psychopharmacologic Drug Advisory Committee
  • Pulmonary-Allergy Drugs Advisory Committee
  • Reproductive Health Drugs Advisory Committee

Medical Devices

  • Device Good Manufacturing Practice Advisory Committee
  • Medical Devices Advisory Committee

Radiation-Emitting Products

  • National Mammography Quality Assurance Advisory Committee
  • Technical Electronic Product Radiation Safety Standards Advisory Committee

Other Advisory Committees and Boards

  • Risk Communication Advisory Committee
  • Science Board to the Food and Drug Administration
  • Science Advisory Board to the National Center for Toxicological Research
  • Veterinary Medicine Advisory Committee
  • Tobacco Products Scientific Advisory Committee
  • Food Advisory Committee
  • Pediatric Advisory Committee
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Brazil makes proposed outsourcing regulations available for comment.

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Puerto Rico to ‘opportunistically pursue’ biologics to regenerate industry.

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Mexico at the vanguard with new combination drug

In the past days, COFEPRIS granted approval for the combination drug containing fluticasone furoate and vilanterol, indicated for treatment of chronic obstructive pulmonary disease (COPD) and asthma. Although the product had already been approved in the US by the FDA in May 2013, for the treatment of COPD, Mexico was the first country worldwide to approve the drug for COPD + asthma simultaneously.

This was a possibility regulatorily, and practically times were so short, (the process took 18 months less than what it would have normally taken) thanks to the Agreement for Innovation, effort of the regulatory authority to promote access of new innovative drugs to the local Mexican market.

Just a couple of days after the product was approved in Mexico, the European Commission, following evaluation by the European Medicines Agency (EMA), granted marketing authorization for the drug for both indications in 31 European countries.

The drug product, developed by the pharmaceutical giant GlaxoSmithKline and the U.S. drug developer Theravance Inc, is a combination of fluticasone furoate, an inhaled corticosteroid, and vilanterol, a long-acting beta2-adrenergic agonist, that offers 24-hour efficacy against asthma and COPD from a once-daily dose, delivered in a new exclusive inhaler.

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Argentina: Site Master File now required by ANMAT for national sites

Starting on November 19th, 2o13, sites in Argentina approved by ANMAT to manufacture or package, in own or contract facility, or import or export, both drug products and APIs, have to submit their Site Master Files (SMF) annually. This is stated in the new disposition 7066/13 that you can access here (in Spanish).

The file has to be submitted to the front desk of the National Institute of Medicines (INAME) in the format of a PDF file in a CD or DVD. Paper submissions are not required nor accepted. All critical changes to the SMF are to be notified with a new SMF.

Companies have 30 days from publication of the regulation to comply and present their SMF. For the annual submission, new SMFs have to be sent 12 months from the last submission.

An annex specifying the required content for the SMF is attached to the new regulation. Here, a general summary:

1 General information on the company
1.1 Company contact information
1.2 Authorized pharmaceutical activities
1.3 Other activities
2 Quality management system
2.1 Quality management system
2.2 Finished product release procedure
2.3 Supplier and contract management (Service and/or system providers, raw material manufacturers and others)
2.4 Quality risk management
2.5 Product quality revision
3 Personnel
3.1 Organigram
4 Installations and equipment
4.1 Installations
4.2 Equipment
5 Document management
6 Production
6.1 Categories of products
6.2 Process validation
6.3 Material and storage management
7 Quality control
8 Distribution, complaints and product recalls
8.1 Distribution
8.2 Complaints, product faults and product recalls
9 Self-inspections
10 Annexes

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Brazil: ANVISA bans Lorcaserin (Belviq)

Today ANVISA, the Brazilian health authority with competence on the control of pharmaceutical products and APIs, banned the manufacturing, import, commercialization, manipulation and use of the API Lorcaserin. Lorcaserin is the drug substance of Belviq, an innovative weight-loss product that inhibits appetite by acting on the central nervous system. The drug was developed by Arena Pharmaceuticals.

In Brazil, APIs are registered independently of the drug products that contain them. API approval is needed to apply for marketing authorization of pharmaceutical products including them. (you can find here an overview of API registration)  In this case, the API Lorcaserin had been approved by ANVISA in July 2013, but no commercial pharmaceutical products containing it were registered. The drug substance was being marketed only in customized compounded prescription medication, formulations prepared in pharmacy labs for individual patients.

Lorcaserin (commercialized as Belviq) was registered in the European Union until May 2013, but the marketing authorization was cancelled then, after the Committee of Drug Products for Human Use of the European Medicine Agency, expressed that the product should have never been approved for the treatment of overweight and obesity. In lab tests, the product showed potential risk of cancer, especially with the long-term use.

The drug is approved in the USA, where is is classified as a Schedule IV drug under the Controlled Substances Act, meaning that is a controlled substance but that has a low potential for abuse relative to the drugs or other substances in schedule III, that has a currently accepted medical use in treatment in the USA, and that abuse of the drug or other substance may lead to limited physical dependence or psychological dependence relative to the drugs or other substances in schedule III. Prescriptions for Schedule IV drugs may be refilled up to five times within a six-month period.

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MoU between Mexican and Chinese health authorities

In the framework of the bilateral agreements recently signed by the presidents of Mexico and China, Enrique Peña Nieto and Xi Jinping, respectively, the representatives of both sanitary agencies, subscribed the first Memorandum of Understanding to strengthen cooperation in matters related to regulations and control of food and drug products, on the last days of October 2013.

Both heads of the regulatory agencies, Mikel Arriola from the Mexican COFEPRIS and Bian Zhenjia, from the Chinese CFDA, expressed a strong commitment on continuing collaboration efforts under their respective laws and regulations.

The main areas of cooperation included in this Memorandum of Understanding are:

  • Exchange of legislation and regulation in matters related to food and health supplies.
  • Information on laws and regulations related to food and health supplies.
  • Exchange of safety information on food and therapeutic products, including pharmacovigilance and alerts.
  • Exchange and cooperation related to Good Laboratory and Good Manufacturing Practices inspections.
  • Exchange and cooperation related to scientific and technologic innovations for food and drug products.

China concentrates one of the biggest health supplies markets in the world, and supplies Mexico with health supply products worth more then 2 billion dollars annually. Products regulated by COFEPRIS represent more than 7% of the total trade volume between Mexico and China.

This MoU illustrates the increase in South-South cooperation, especially that led by the fast-growing BRIC countries.

It would be very interesting to see advances in cooperation of harmonization of GMP inspection/certification, especially considering that Mexico requires GMP verification of API sites for drug product registration, and that China is a very important supplier of APIs.

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Brazil: Overview of API registration

In Brazil, the health authority (ANVISA) will require that all Active Pharmaceutical Ingredients (APIs) manufactured in Brazil, imported for manufacturing of drug products, or included in imported finished products, are registered with the agency.

This regulation has been put in place in 2009, and the implementation has been gradual: ANVISA created a scheme that includes the different API categories in different “waves” of implementation.

In the first implementation wave (deadlines to register in 2010) the following drug substances were included: Cyclosporine, Clozapine, Clindamycin Chlorhydrate, Ciclophosphamide, Ciprofloxacin, Methotrexate, Carbamazepine, Lithium Carbonate, Phenytoin, Sodium Phenytoin, Lamivudine, Penicillamine, Thiabendazole, Efavirenz, Nevirapine, Rifampicin, Ritonavir, Zidovudine, Acyclovir and Ampicillin.

In June 2013, the second implementation wave was announced, including the following substances: Azithromycin, Benzylpenicillin, Cabergoline, Carboplatin, Cephalexin, Cephalothin, Ceftazidime, Cisplatin, Clarithromycin, Ceftriaxone and their respective salts, esters, ethers and hydrates, and the salts, esters, ethers and hydrates of the APIs included in the first tier. Companies can register the APIs starting on the 1st of January of 2014. From the 1st of January of 2015, only companies that have already applied for API registration can import or commercialize those APIs or drug products containing those APIs. From the 1st of January of 2016, only companies that hold the (approved) registration of the APIs can import or commercialize those APIs or drug products containing those APIs.

Here is an extract of the technical regulation on the matter. You can consult the full regulation (in English) in the following link.

Technical Regulation for the registration of Active Pharmaceutical Ingredients (APIs) in Brazil

APIs, including imported ones, shall not be industrialized, exposed for sale, or commercialized in Brazil before being registered by ANVISA, except the API that will be used for scientific or technological research, as well as for research and development of formulations.

The registration of APIs destined for export only will be optional.

The registration will be valid for five years and may be revalidated for equal and successive periods of time, the initial record number being maintained. Registration revalidation shall be requested in the first semester of the last valid year, from the date of publication of the registration, being considered automatically revalidated, regardless of decision, if the latter is not announced until the date its validation is terminated. The preclusion of product registration will be declared, if its revalidation is not requested within the period of time above mentioned.

The registration of the APIs will not be granted when the conditions, requirements, and procedures provided for in the regulation are not met. In case of emergency, or in a temporary situation, ANVISA may excuse from registration the APIs for exclusive use in the production of drugs to be used in public health programs by the Ministry of Health and their related organisms. This excuse from registration of the APIs will be authorized exclusively by Anvisa Collegiate Board of Directors, in a formal and public document signed by the Director-President.

The companies settled in Brazil that manufacture or import APIs must adjust their activities to the provisions hereof, in accordance with the schedule approved by the Collegiate Board of Directors. The publication of the schedule referred to herein will be issued in the form of a normative document by Anvisa Collegiate Board of Directors, where the deadline for adequacy will be established.

The APIs present in the formulation of imported medical drugs, either in the form of semi-finished or finished drug product, must be registered according to the provisions hereof.

The non-compliance of the provisions in this Resolution and in the Regulation approved by it is considered as sanitary infraction, and is subject to the appropriate civil, administrative, and penal liabilities.

This Resolution is applied to synthetic APIs used in the production of drug products. The registration of the APIs used in herbal drug products, dynamized medicines, and biological products, including sera and vaccines, are not included in this regulation.

DOCUMENTS FOR THE REGISTRATION

When protocolizing the petition of registration of API, the company shall protocolize a single process, containing the following documents:

  • Petition forms properly filled out.
  • Original copy of the receipt of payment of the health surveillance inspection fee, or exemption probative document, when applicable.
  • Copy of the updated Operation License (Sanitary Permit) of the company.
  • Copy of the Operation Authorization of the company, and Special Operation Authorization, when applicable, published in the Federal Official Gazette.
  • Copy of the updated Certificate of Good Manufacturing Practices and Control of Pharmaceutical Ingredients, issued by Anvisa, or probative document of the Operational Technical Conditions issued by the local health authority, or a protocol requesting inspection by the local health authority, as long as a satisfactory situation according to the last inspection is presented.
  • For imported APIs, copy of the Certificate of Good Manufacturing Practices and Control of Pharmaceutical Ingredients, issued by Anvisa, or a protocol requesting inspection by Anvisa, as long as a satisfactory situation according to the last inspection is presented.
  • Copy of the Certificate of Technical Responsibility in force, related to the company requesting the registration, issued by the Regional Council of Chemistry or Pharmacy.
  • Probative document of the API record at Anvisa.
  • Documentation required in the legislation in force on the control of the Transmissible Spongiform Encephalopathy (TSE).
  • Technical report containing the information described below.

All of the following documentation shall be presented on letterhead paper of the API manufacturing company in Portuguese language. The drug manufacturers have the option of sending directly to ANVISA the documentation described herein, duly identified with the related process number.

TECHNICAL INFORMATION ON THE API

The registration documentation must also contain the following information:

  • General information:

a) Nomenclature: Common Brazilian Denomination, or International Common Denomination, in case the former is not available;
b) CAS number;
c) Chemical name;
d) Synonyms with complete reference;
e) Molecule and structure formula;
f) Molecular weight;
g) Physical form;
h) Fusion or ebullition point;
i) Solubility;
j) Loss by drying;
k) Physical characteristics (crystalline, amorphous, particle size, solvatation, etc.);
l) pka and pH;
m) Conservation cautions;
n) Organoleptic properties.

  • API manufacturing process:

a) Manufacturer(s): name, complete address, company responsible for each phase of the manufacturing process and quality control (including contracts and subcontracts);
b) Description of productive process, including materials, equipment, and operation conditions (for example, temperature, pressure, pH, time, speed, agitation ranges, etc.); and the process controls;
c) Identification of critical phases, including the respective tests and acceptance criteria;
d) Flow chart of the productive process, indicating the formation of intermediary products and possible impurities, including explanation of the respective chemical structures;
e) Indication of raw materials, solvents, catalyzers, etc;
f) Indicate production and yield scale;
g) Specifications of raw materials and packing materials.

  • Characterization: Physical-chemical essays that allow for the duly characterization of API structure:

a) Analyses of an industrial batch, producing evidence of functional groups, chemical structure, and molecule formula expected for the API;
b) Possible isomers;
c) Polymorphism, describing the characteristics of the polymorph used, and of other ones related to the API.

  • Impurity profile:

a) Description of potential impurities, resulting from the synthesis, with brief description and indication of origin;
b) Organic impurities (of the process and related substances): (starting) raw materials, related products, intermediary products, degradation products, reagents and catalyzers;
c) Inorganic impurities: reagents and catalyzers, heavy metals, inorganic salts;
d) Residual solvents.

  • API quality control:

Specifications
a) (?)
b) Aspect;
c) Identification;
d) Dosage/ proportion;
e) Impurities (organic, inorganic, and individual solvents);
f) Physical-chemical properties (pH, fusion point etc.);
g) Granulometric distribution;
h) Polymorphism, including adopted analytical methodology and test results to determine the probable polymorphic agents of the ingredient;
i) For ingredients presenting chirality, data on the proportions of stereoisomers;
j) Humidity;
k) Microbiological limits: sterility, endotoxins (if applicable);
l) Specific optic rotation (if applicable).
Copy of report on quality control of three batches produced, with API identification, batch number, reference values and results of tests carried out.
Description of analytical methodology: Validation of analytical methodology according to specific technical regulation in force for the
validation of analytical and bioanalytical methods, when pharmacopoeia methodology is not used. In the case of pharmacopoeia methodology, the company shall present co-validation of the method.

  • Packaging Material: description and specification of primary packaging material.
  • Stability and Photostability Report: Stability and photostability studies must be carried out following the specific technical regulation in force in Brazil. 

DOCUMENTATION FOR REGISTRATION RENEWAL:

For the renewal of registration of APIs, the company shall present the following documents:

  • Petition forms duly filled out;
  • Original copy of the receipt of payment of the health surveillance inspection fee, or exemption probative document, when applicable.
  • Copy of the Certificate of Good Manufacturing Practices and Control issued by Anvisa for the API registered, or a copy of the protocol requesting inspection for the purposes of issuing the certificate aforementioned, as long as a satisfactory situation according to the last inspection is presented.
  • In the case of ingredients registered exclusively for export purposes, according to this regulation, a probative document of export must be presented.
  • List of all post-registration alterations and/ or inclusions occurred during the last valid period of the product registration.
  • Conclusive results from long duration stability studies, according to a specific guide defined by Anvisa.
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